viernes, 30 de septiembre de 2022

Human Gene Therapy - September 2022

Human Gene Therapy - September 2022 SPECIAL ISSUE 29th Annual Congress of the ESGCT Guest Editor: Andrew Baker, PhD Enjoy complimentary access to the latest digital edition of Human Gene Therapy. The Editorial Staff of Human Gene Therapy is pleased to present this Special Issue on the occasion of the 2022 Congress of the European Society of Gene and Cell Therapy and the British Society of Gene and Cell Therapy. This issue includes a number of timely original research and review articles, providing insights into the ongoing progress in the field, as the world moves out of the global COVID-19 pandemic and the gene therapy community begins to assemble in-person once again to present, discuss, and debate new scientific and clinical findings. Read featured articles below and you can access the full digital edition. ESGCT 2022: The New Normal for the Gene Therapy Community Terence R. Flotte Read Now [ Open Access ] Update on Viral Gene Therapy Clinical Trials for Retinal Diseases Shun-Yun Cheng and Claudio Punzo Read Now Central Nervous System Gene Therapy: Present Developments and Emerging Trends Accelerating Industry-Academia Pathways Margareta Rybarikova, Amanda Almacellas-Barbanoj, Stéphanie Schorge, and Nicole Déglon Read Now Liver Gene Therapy Amit C. Nathwani, Jenny McIntosh, and Rose Sheridan Read Now Progress in Respiratory Gene Therapy Gerry McLachlan, Eric W.F.W. Alton, A. Christopher Boyd, Nora K. Clarke, Jane C. Davies, Deborah R. Gill, Uta Griesenbach, Jack W. Hickmott, Stephen Hyde, Kamran M. Miah, and Claudia Juarez Molina Read Now Long-Term Disease Prevention with a Gene Therapy Targeting Oligodendrocytes in a Mouse Model of Adrenomyeloneuropathy Yasemin Özgür-Günes, Malha Chedik, Catherine Le Stunff, Claire-Maëlle Fovet, and Pierre Bougnères Read Now Methods for Extrapolating Survival Analyses for the Economic Evaluation of Advanced Therapy Medicinal Products Will A.S. Hardy and Dyfrig A. Hughes Read Now [ Open Access ] Insight and Development of Advanced Recombinant Adeno-Associated Virus Analysis Tools Exploiting Single-Particle Quantification by Multidimensional Droplet Digital PCR Jeanette Zanker, Sara Lázaro-Petri, Daniela Hüser, Regine Heilbronn, and Adrien Savy Read Now

Federal Register :: Request for Information: SAMHSA's Role in Possible Agency Actions Regarding Mental Health and Substance Use Wellbeing in the Context of Climate Change and Health Equity

Federal Register :: Request for Information: SAMHSA's Role in Possible Agency Actions Regarding Mental Health and Substance Use Wellbeing in the Context of Climate Change and Health Equity

Virtual Lunch & Learn: SAMHSA’s Office of Behavioral Health Equity Celebrates Hispanic Heritage Month Thursday, October 6, 2022 12:00 PM – 1:00 PM ET

Iniciar reunión - Zoom Join SAMHSA’s Office of Behavioral Health Equity for a Lunch & Learn to celebrate Hispanic Heritage Month. This virtual learning opportunity will discuss successes of the Familia Adelante intervention with its developer, Dr. Richard Cervantes and spotlight NNEDLearn 2022 Familia Adelante participants through a digital story viewing. The Familia Adelante participants will share about their efforts with implementation of this intervention. In partnership with the National Latino Behavioral Health Association executive director, Mr. Fred Sandoval, MPA, this session will also host an exchange about how SAMHSA can increase behavioral health equity for the Hispanic/Latinx community. Please click the link below to join this virtual session: https://www.zoomgov.com/j/1616697635 Webinar ID: 161 669 7635 Passcode: 679743 Or One tap mobile: US: +16468287666,,1616697635#,,,,*679743# or +15512851373,,1616697635#,,,,*679743# Or Telephone Dial: US: +1 646 828 7666 or +1 551 285 1373

Overpatented-Overpriced-2022-FINAL.pdf

Overpatented-Overpriced-2022-FINAL.pdf

New report ignores benefits of patent system to innovation and patients

New report ignores benefits of patent system to innovation and patients

In conversation with Freya Spielberg, MD, MPH | PSNet

In conversation with Freya Spielberg, MD, MPH | PSNet

In conversation with Jack Westfall, MD, MPH | PSNet

In conversation with Jack Westfall, MD, MPH | PSNet

Primary Care and Patient Safety: Opportunities at the Interface | PSNet

Primary Care and Patient Safety: Opportunities at the Interface | PSNet

Burnout | PSNet

Burnout | PSNet

Be Picky about your PICCs—Fragmented Care and Poor Communication at Discharge Leads to a PICC without a Plan. | PSNet

Be Picky about your PICCs—Fragmented Care and Poor Communication at Discharge Leads to a PICC without a Plan. | PSNet

2022 National Strategy to Support Family Caregivers | ACL Administration for Community Living

2022 National Strategy to Support Family Caregivers | ACL Administration for Community Living

Quality of Care External Quality Review | Medicaid

Quality of Care External Quality Review | Medicaid

Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration - 10/24/2022 | FDA

Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration - 10/24/2022 | FDA

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments | FDA

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments | FDA

ISPOR - Risk Communication for Discrete Choice Experiments

ISPOR - Risk Communication for Discrete Choice Experiments

Do PRO Measures Function the Same Way for all Individuals With Heart Failure? - Journal of Cardiac Failure

Do PRO Measures Function the Same Way for all Individuals With Heart Failure? - Journal of Cardiac Failure

Medical Devices Virtual Public Meeting - Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation - 09/30/2020 | FDA

Medical Devices Virtual Public Meeting - Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation - 09/30/2020 | FDA

The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | FDA

The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | FDA

CMS Innovation Center Homepage | CMS Innovation Center

CMS Innovation Center Homepage | CMS Innovation Center

Data & Reports | CMS Innovation Center

Data & Reports | CMS Innovation Center

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

4th Circuit En Banc Judgment Affirms District Court Decision in Best Price Stacking Case

4th Circuit En Banc Judgment Affirms District Court Decision in Best Price Stacking Case

A Historic Day in Drug Development: FDA Approves Amylyx’s Drug to Treat ALS, Demonstrating FDA’s Application of Appropriate Flexibility in Rare Diseases

A Historic Day in Drug Development: FDA Approves Amylyx’s Drug to Treat ALS, Demonstrating FDA’s Application of Appropriate Flexibility in Rare Diseases

Webinar: Improving Nonsurgical Management of Urinary Incontinence in Women | AcademyHealth

Webinar: Improving Nonsurgical Management of Urinary Incontinence in Women | AcademyHealth

EvidenceNOW: Managing Urinary Incontinence | Agency for Healthcare Research and Quality

EvidenceNOW: Managing Urinary Incontinence | Agency for Healthcare Research and Quality

The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | FDA

The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | FDA

What’s New for Biologics | FDA

What’s New for Biologics | FDA

jueves, 29 de septiembre de 2022

How is physicians' implicit prejudice against the obese and mentally ill moderated by specialty and experience? | PSNet

How is physicians' implicit prejudice against the obese and mentally ill moderated by specialty and experience? | PSNet

Health and Economic Costs of Chronic Diseases | CDC

Health and Economic Costs of Chronic Diseases | CDC

About Chronic Diseases | CDC

About Chronic Diseases | CDC

New Report: Nearly 800 medicines in development to treat chronic condition

New Report: Nearly 800 medicines in development to treat chronic condition

Exploring care left undone in pediatric nursing. | PSNet

Exploring care left undone in pediatric nursing. | PSNet

Diagnostic delays in infectious diseases. | PSNet

Diagnostic delays in infectious diseases. | PSNet

Changes in unprofessional behaviour, teamwork, and co-operation among hospital staff during the COVID-19 pandemic. | PSNet

Changes in unprofessional behaviour, teamwork, and co-operation among hospital staff during the COVID-19 pandemic. | PSNet

Adding automation and independent dual verification to reduce wrong blood in tube (WBIT) events. | PSNet

Adding automation and independent dual verification to reduce wrong blood in tube (WBIT) events. | PSNet

What is the Role of Non-invasive Imaging in Diagnostics?

What is the Role of Non-invasive Imaging in Diagnostics?

How a major COVID-19 outbreak occurred in a naïve and vaccinated population in Taiwan with a limited number of entry events

How a major COVID-19 outbreak occurred in a naïve and vaccinated population in Taiwan with a limited number of entry events

Primary Care Doctors' Knowledge of IPF Could Speed Up Diagnoses

Primary Care Doctors' Knowledge of IPF Could Speed Up Diagnoses

Female Docs Rarely Earn Highest Drug, Device Payouts: Study

Female Docs Rarely Earn Highest Drug, Device Payouts: Study

BE labeling Rule Challenge Largely Fails but Court Takes Issue with Electronic and Text Message Disclosure Options

BE labeling Rule Challenge Largely Fails but Court Takes Issue with Electronic and Text Message Disclosure Options

Financial Toxicity and Cancer Treatment (PDQ®)–Health Professional Version - NCI

Financial Toxicity and Cancer Treatment (PDQ®)–Health Professional Version - NCI

Register Today: AHRQ Webinar on Optimizing Data Visualization to Improve Care

Register Today: AHRQ Webinar on Optimizing Data Visualization to Improve Care

Providing Over-the-Counter Monograph Submissions in Electronic Format | FDA

Providing Over-the-Counter Monograph Submissions in Electronic Format | FDA

Study Data Standards Update for CBER: Your Guide to a Successful Submission - 10/05/2022 | FDA

Study Data Standards Update for CBER: Your Guide to a Successful Submission - 10/05/2022 | FDA

Science and Engineering Laboratories: Updates from FDA/CDRH

Science and Engineering Laboratories: Updates from FDA/CDRH

2022 National Strategy to Support Family Caregivers | ACL Administration for Community Living

2022 National Strategy to Support Family Caregivers | ACL Administration for Community Living

Suicide Warning Signs and Prevention Strategies for Older Adults | SAMHSA

Suicide Warning Signs and Prevention Strategies for Older Adults | SAMHSA

Medicare Beneficiaries at a Glance - Centers for Medicare & Medicaid Services Data

Medicare Beneficiaries at a Glance - Centers for Medicare & Medicaid Services Data

Data Tables | CMS

Data Tables | CMS

Patient Science and Engagement Updates from CDRH

Patient Science and Engagement Updates from CDRH

Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins - 10/13/2022 | FDA

Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins - 10/13/2022 | FDA

FDA Broad Agency Announcement Day 2022 - 12/06/2022 | FDA

FDA Broad Agency Announcement Day 2022 - 12/06/2022 | FDA

2020 MCBS Financial Well-Being of Medicare Beneficiaries | CMS

2020 MCBS Financial Well-Being of Medicare Beneficiaries | CMS

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

What’s New for Biologics | FDA

What’s New for Biologics | FDA

miércoles, 28 de septiembre de 2022

Federal Register :: Request for Information on Person-Centered Care Planning for Multiple Chronic Conditions (MCC)

Federal Register :: Request for Information on Person-Centered Care Planning for Multiple Chronic Conditions (MCC)

FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease | FDA

FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease | FDA

In conversation with Jack Westfall, MD, MPH | PSNet

In conversation with Jack Westfall, MD, MPH | PSNet

In conversation with Freya Spielberg, MD, MPH | PSNet

In conversation with Freya Spielberg, MD, MPH | PSNet

Challenges and strategies for patient safety in primary care: a qualitative study. | PSNet

Challenges and strategies for patient safety in primary care: a qualitative study. | PSNet

Modes of failure in venous thromboembolism prophylaxis. | PSNet

Modes of failure in venous thromboembolism prophylaxis. | PSNet

Associations of physician burnout with career engagement and quality of patient care: systematic review and meta-analysis. | PSNet

Associations of physician burnout with career engagement and quality of patient care: systematic review and meta-analysis. | PSNet

AHRQ Webinar: Optimizing Data Visualization to Improve Care | Digital Healthcare Research - Register Now for Oct. 19 Webinar on Optimizing Data Visualization To Improve Care

AHRQ Webinar: Optimizing Data Visualization to Improve Care | Digital Healthcare Research

Opioid dependence and overdose after surgery: rate, risk factors, and reasons. | PSNet

Opioid dependence and overdose after surgery: rate, risk factors, and reasons. | PSNet

Sustained improvement in quality of patient handoffs after orthopaedic surgery I-PASS intervention. | PSNet

Sustained improvement in quality of patient handoffs after orthopaedic surgery I-PASS intervention. | PSNet

Frontiers in measuring structural racism and its health effects. | PSNet

Frontiers in measuring structural racism and its health effects. | PSNet

Developing and Assessing the Validity of Claims-based Indicators of Frailty & Functional Disabilities in Electronic Health Records | Agency for Healthcare Research and Quality

Developing and Assessing the Validity of Claims-based Indicators of Frailty & Functional Disabilities in Electronic Health Records | Agency for Healthcare Research and Quality

AHRQ Announces New Healthcare System Challenge Competition | Agency for Healthcare Research and Quality

AHRQ Announces New Healthcare System Challenge Competition | Agency for Healthcare Research and Quality

AHRQ Challenge on Integrating Healthcare System Data With Systematic Review Findings | Agency for Healthcare Research and Quality

AHRQ Challenge on Integrating Healthcare System Data With Systematic Review Findings | Agency for Healthcare Research and Quality

Trends and Distribution of In-Hospital Mortality Among Pregnant and Postpartum Individuals by Pregnancy Period - PubMed

Trends and Distribution of In-Hospital Mortality Among Pregnant and Postpartum Individuals by Pregnancy Period - PubMed

AHRQ Releases Primer for Reducing Healthcare Carbon Emissions | Agency for Healthcare Research and Quality

AHRQ Releases Primer for Reducing Healthcare Carbon Emissions | Agency for Healthcare Research and Quality

Reducing Healthcare Carbon Emissions: A Primer on Measures and Actions for Healthcare Organizations to Mitigate Climate Change | Agency for Healthcare Research and Quality

Reducing Healthcare Carbon Emissions: A Primer on Measures and Actions for Healthcare Organizations to Mitigate Climate Change | Agency for Healthcare Research and Quality

Perceived Susceptibility to Chronic Kidney Disease and Hypertension Self-Management among Black and White Live Kidney Donors - PubMed

Perceived Susceptibility to Chronic Kidney Disease and Hypertension Self-Management among Black and White Live Kidney Donors - PubMed

A prospective observational study of video laryngoscopy-guided coaching in the pediatric intensive care unit - PubMed

A prospective observational study of video laryngoscopy-guided coaching in the pediatric intensive care unit - PubMed

Temporal Trends in Antimicrobial Prescribing During Hospitalization for Potential Infection and Sepsis - PubMed

Temporal Trends in Antimicrobial Prescribing During Hospitalization for Potential Infection and Sepsis - PubMed

Assessing proximate intermediates between ambient temperature, hospital admissions, and mortality in hemodialysis patients - PubMed

Assessing proximate intermediates between ambient temperature, hospital admissions, and mortality in hemodialysis patients - PubMed

Mental Health Emergency Department Visits by Children Before and During the COVID-19 Pandemic - PubMed

Mental Health Emergency Department Visits by Children Before and During the COVID-19 Pandemic - PubMed

Therapeutic Hyperthermia Is Associated With Improved Survival in Afebrile Critically Ill Patients With Sepsis: A Pilot Randomized Trial - PubMed

Therapeutic Hyperthermia Is Associated With Improved Survival in Afebrile Critically Ill Patients With Sepsis: A Pilot Randomized Trial - PubMed

Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits - PubMed

Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits - PubMed

Data Infographics | Agency for Healthcare Research and Quality

Data Infographics | Agency for Healthcare Research and Quality

Opioid Use Among Elderly & Non-Elderly Adults by Socioeconomic Characteristics | Agency for Healthcare Research and Quality

Opioid Use Among Elderly & Non-Elderly Adults by Socioeconomic Characteristics | Agency for Healthcare Research and Quality

Recommendation: Syphilis Infection in Nonpregnant Adolescents and Adults: Screening | United States Preventive Services Taskforce

Recommendation: Syphilis Infection in Nonpregnant Adolescents and Adults: Screening | United States Preventive Services Taskforce

AHRQ Challenge on Integrating Healthcare System Data With Systematic Review Findings | Agency for Healthcare Research and Quality

AHRQ Challenge on Integrating Healthcare System Data With Systematic Review Findings | Agency for Healthcare Research and Quality

AHRQ Announces New Healthcare System Challenge Competition | Agency for Healthcare Research and Quality

AHRQ Announces New Healthcare System Challenge Competition | Agency for Healthcare Research and Quality

Clinical Decision Support Software | FDA

Clinical Decision Support Software | FDA

What’s New for Biologics | FDA

What’s New for Biologics | FDA

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials | FDA

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials | FDA

HCUP-US Statistical Briefs Chronological

HCUP-US Statistical Briefs Chronological

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

FDA Safety Communications: A Potential Provider Pitfall

FDA Safety Communications: A Potential Provider Pitfall

martes, 27 de septiembre de 2022

The Pandemic Is NOT Over

The Pandemic Is NOT Over

Tips for Young Adults: Coping with Mass Violence | SAMHSA Publications and Digital Products

Tips for Young Adults: Coping with Mass Violence | SAMHSA Publications and Digital Products

A Guide to Managing Stress for Disaster Responders and First Responders | SAMHSA Publications and Digital Products

A Guide to Managing Stress for Disaster Responders and First Responders | SAMHSA Publications and Digital Products

How to get the Inside Track for Your Monkeypox EUA

How to get the Inside Track for Your Monkeypox EUA

Developing and Assessing the Validity of Claims-based Indicators of Frailty & Functional Disabilities in Electronic Health Records | Agency for Healthcare Research and Quality

Developing and Assessing the Validity of Claims-based Indicators of Frailty & Functional Disabilities in Electronic Health Records | Agency for Healthcare Research and Quality

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

New AHRQ Competition Examines Integrating Health System Data With Systematic Review Findings

Challenge.Gov

FACT SHEET: Protecting Seniors by Improving Safety and Quality of Care in the Nation’s Nursing Homes - The White House

FACT SHEET: Protecting Seniors by Improving Safety and Quality of Care in the Nation’s Nursing Homes - The White House

Skilled Nursing Facility Enrollments - Centers for Medicare & Medicaid Services Data

Skilled Nursing Facility Enrollments - Centers for Medicare & Medicaid Services Data

Read the Newly Released AHRQ Digital Healthcare Research Program Year in Review

Read the Newly Released AHRQ Digital Healthcare Research Program Year in Review

COVID-19 Noticias / Opiniones CHEQUEADAS EN INGLÉS y otros idiomas

COVID-19 Noticias / Opiniones CHEQUEADAS EN INGLÉS y otros idiomas

FDA scolds Catalent over quality control at Covid-shot plant - STAT

FDA scolds Catalent over quality control at Covid-shot plant - STAT

Lockdowns led to lower life satisfaction in Australia

Lockdowns led to lower life satisfaction in Australia

COVID-19 Informes Científicos CHEQUEADOS COMPLETOS REVISADOS (full texts)

COVID-19 Informes Científicos CHEQUEADOS COMPLETOS REVISADOS (full texts)

Emotional Exhaustion Among US Health Care Workers Before and During the COVID-19 Pandemic, 2019-2021 | Health Care Workforce | JAMA Network Open | JAMA Network

Emotional Exhaustion Among US Health Care Workers Before and During the COVID-19 Pandemic, 2019-2021 | Health Care Workforce | JAMA Network Open | JAMA Network

Indice General de Autoevaluaciones

Indice General de Autoevaluaciones

Novedades COVID-19

Novedades COVID-19

COVID-19 ESPECIALISTAS opinan Expertos Invitados (Castellano)

COVID-19 ESPECIALISTAS opinan Expertos Invitados (Castellano)

COVID-19 Noticias / Opiniones CHEQUEADAS

COVID-19 Noticias / Opiniones CHEQUEADAS

lunes, 26 de septiembre de 2022

Ethical Considerations for Clinical Investigations of Medical Products Involving Children | FDA

Ethical Considerations for Clinical Investigations of Medical Products Involving Children | FDA

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials | FDA

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials | FDA

What’s New for Biologics | FDA

What’s New for Biologics | FDA

Ensuring Equitable Health Access for All | Aspen Ideas

Ensuring Equitable Health Access for All | Aspen Ideas

Merck Foundation Launches $20 Million Initiative to Advance Equity in U.S. Cancer Care - Merck.com

Merck Foundation Launches $20 Million Initiative to Advance Equity in U.S. Cancer Care - Merck.com

Talent: Expanding Opportunities to Work and Succeed in Our Industry

Talent

Personal Information - PhRMA’s Pathways to Success: Virtual Graduate Summit and Career Expo on September 28-29

Personal Information - Pathways to Success: Virtual Graduate Summit & Career Expo

Infographic: Incomes Climb for Young Physicians

Infographic: Incomes Climb for Young Physicians

Noted Oncologist Ponders Death, Life, Care Inequities

Noted Oncologist Ponders Death, Life, Care Inequities

La accesibilidad a Atención Primaria no está garantizada

La accesibilidad a Atención Primaria no está garantizada

IDIS alerta del peligro de restringir la colaboración público privada

IDIS alerta del peligro de restringir la colaboración público privada

ANUARIO DE LA SANIDAD Y DEL MEDICAMENTO EN ESPAÑA.

Sin título-2

Text messages may help speed up decision-making in nursing homes, improve quality of care

Text messages may help speed up decision-making in nursing homes, improve quality of care

Cancer survival rate rises in the US

Cancer survival rate rises in the US

Study compares monkeypox PCR testing protocols and efficiency at two U.S. reference labs

Study compares monkeypox PCR testing protocols and efficiency at two U.S. reference labs

Study of 9 million Swedes shows rapidly declining effectiveness of COVID vaccines against Omicron

Study of 9 million Swedes shows rapidly declining effectiveness of COVID vaccines against Omicron

Are we consuming microplastics through take-out food?

Are we consuming microplastics through take-out food?

Embedded bias: How medical records sow discrimination

Embedded bias: How medical records sow discrimination

Is covid ‘under control’ in the US? Experts say yes

Is covid ‘under control’ in the US? Experts say yes

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

domingo, 25 de septiembre de 2022

Tools And Education Can Reduce Sugary Drink Consumption For Low-Income Latino Families

Tools And Education Can Reduce Sugary Drink Consumption For Low-Income Latino Families

Global Health: The Leopoldina Annual Assembly Looks At Ways Of Achieving Global Health And Equity

Global Health: The Leopoldina Annual Assembly Looks At Ways Of Achieving Global Health And Equity

World Sepsis Month: Increasing Sepsis Awareness, Patient Support, and Improving Survivor Outcomes

World Sepsis Month: Increasing Sepsis Awareness, Patient Support, and Improving Survivor Outcomes

What’s New for Biologics | FDA

What’s New for Biologics | FDA

Health digital twins as tools for precision medicine: Considerations for computation, implementation, and regulation KP Venkatesh et al, NPJ Digital Medicine, Sepetmber 22, 2022

Main|Search|PHGKB

Main|Artificial intelligence|PHGKB

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Main|Precision medicine|PHGKB

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Main|Pathogen genomics|PHGKB

Main|Search|PHGKB

Clinical Performance and Trends During the First Two Months of Monkeypox Virus PCR Testing at Two United States Reference Labs NAP Lieberman et al, MEDRXIV, September 21, 2022

Main|Search|PHGKB

Main|Digital health|PHGKB

Main|Search|PHGKB

Main|Electronic health records|PHGKB

Main|Search|PHGKB

Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study I Kracalik et al, The Lancet Infectious Diseases, September 2022

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Main|Precision health|PHGKB

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Specific PHGKB|Infectious Diseases|PHGKB

Specific PHGKB|<bean:write name="specificPHGKBForm" property="topic" />|PHGKB

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Specific PHGKB|Environmental Health PHGKB|PHGKB

Specific PHGKB|Environmental Health PHGKB|PHGKB

CDC-Authored Publications Update|PHGKB

CDC-Authored Publications Update|PHGKB

Precision Health Database| Non-Genomics Precision Health Weekly Scan|PHGKB

Precision Health Database| Non-Genomics Precision Health Weekly Scan|PHGKB

Advanced Molecular Detection Clips Database|AMD Clips|PHGKB

Advanced Molecular Detection Clips Database|AMD Clips|PHGKB

Precision Health Database| Genomics Precision Health Weekly Scan|PHGKB

Precision Health Database| Genomics Precision Health Weekly Scan|PHGKB

Host Genomics and COVID-19: Implications for Clinical and Public Health Practice | CDC - October 6, 2022, 11:00 am -12:00 noon ET

Host Genomics and COVID-19: Implications for Clinical and Public Health Practice | CDC

Trends in Tier 1 Genomic Applications 2013-2022 | Blogs | CDC

Trends in Tier 1 Genomic Applications 2013-2022 | Blogs | CDC

Calling on All of Us Public Health Scientists | Blogs | CDC

Calling on All of Us Public Health Scientists | Blogs | CDC

From All of Us Research to All of Us in the Real World: Using the All of Us Research Program Data to Improve Population Health | CDC - September 29, 9:30-11:00 am, EDT

From All of Us Research to All of Us in the Real World: Using the All of Us Research Program Data to Improve Population Health | CDC

sábado, 24 de septiembre de 2022

International Recovery Day | Celebrating Recovery Globally - A Recovery Month Panel in Partnership with Mobilize Recovery, “Young Adults in Recovery—Making Small Choices, Every Day,” will take place on International Recovery Day Friday, September 30, 2022 at 1:15 PM ET.

International Recovery Day | Celebrating Recovery Globally

National Recovery Month 2022 | SAMHSA

National Recovery Month 2022 | SAMHSA

DTAC Bulletin: American Indians and Alaska Natives and Disaster Behavioral Health

DTAC Bulletin: American Indians and Alaska Natives and Disaster Behavioral Health

DTAC Bulletin: Climate Change and New Preparedness Needs

DTAC Bulletin: Climate Change and New Preparedness Needs

988 Social Media Shareables | SAMHSA

988 Social Media Shareables | SAMHSA

Adapting Evidence-based Practices for Under-resourced Populations | SAMHSA Publications and Digital Products

Adapting Evidence-based Practices for Under-resourced Populations | SAMHSA Publications and Digital Products

National Preparedness Month: Planning for Disasters and Emergencies | SAMHSA

National Preparedness Month: Planning for Disasters and Emergencies | SAMHSA

Save the Date—Eating Disorders Among Veterans: A Novel Tool for Screening and Referral in Primary Care—Webinar Wednesday, October 19, 2022 1:00 PM ET

Online Survey Software | Qualtrics Survey Solutions

It's Just Tech... An Interactive Tech Training Series for Providers and Caretakers Working and Living with the IDD Community—Webinar Series Thursday, October 6, 2022 5:00 PM ET

It's Just Tech...Session 1 | Mental Health Technology Transfer Center (MHTTC) Network

Risk of Substance Use Disorders in NeuroDiverse Populations—Clinical Roundtable Webinar Thursday, October 6, 2022 3:00 PM ET

Risks of Substance Use Disorders in NeuroDiverse Populations - PCSS

Confronting Implicit Bias in Society and Ourselves—A Four-Part Webinar Series This series will occur on every Wednesday in October starting Wednesday, October 5 at 3:00 PM ET

Inscripción a la reunión - Zoom

Stigma Series: Challenging the Stigma Surrounding Addiction Part 1 | Prevention Technology Transfer Center (PTTC) Network - Wednesday, October 5, 2022 1:00 PM ET

Stigma Series: Challenging the Stigma Surrounding Addiction Part 1 | Prevention Technology Transfer Center (PTTC) Network

Adapting Evidence-based Interventions for Under-resourced Populations—Webinar Tuesday, October 4, 2022 1:00 PM ET

Inscripción a la reunión - Zoom

Applying Economic Evaluation to Your Research—Webinar Friday, September 30, 2022 2:00 PM ET

Inscripción al seminario web - Zoom

Recreational and Medical Cannabis: What Providers Need to Know (SAPC-UCLA Lecture Series) | Technology Transfer Centers - Friday, September 30, 2022 1:00 PM ET

Recreational and Medical Cannabis: What Providers Need to Know (SAPC-UCLA Lecture Series) | Technology Transfer Centers

Trauma Strategies for Peer Support Using Self Care (CARC/CRPA CE in addition to OASAS-approved hours) | Technology Transfer Centers - Friday, September 30, 2022, 10:00 AM ET

Trauma Strategies for Peer Support Using Self Care (CARC/CRPA CE in addition to OASAS-approved hours) | Technology Transfer Centers

For The Culture: CAARD & The Black Recovery Movement Tickets, Multiple Dates | Eventbrite - Thursday, September 29, 2022 & Thursday, October 27, 2022 7:00 PM ET

For The Culture: CAARD & The Black Recovery Movement Tickets, Multiple Dates | Eventbrite

The Digital Peer Support Specialists Role in Health and Wellness - Thursday, September 29, 2022 3:00 PM ET

The Digital Peer Support Specialists Role in Health and Wellness

How Using Contingency Management Can Support Families Affected by Substance Use Disorders—Webinar Thursday, September 29, 2022 1:30 PM ET

Inscripción al seminario web - Zoom

De-escalation - Basic Tools for Social Workers (via Zoom - 9/29/22) | Technology Transfer Centers - Thursday, September 29, 2022 9:00 AM ET

De-escalation - Basic Tools for Social Workers (via Zoom - 9/29/22) | Technology Transfer Centers

Substance Use and Mental Illness among BIPOC: Bridging Gaps in Equity—Webinar Wednesday, September 28, 2022 3:00 PM ET

Opioid Response Network

Bullying and Its Impact on Mental Health | Mental Health Technology Transfer Center (MHTTC) Network - Wednesday, September 28, 2022 2:00 PM ET

Bullying and Its Impact on Mental Health | Mental Health Technology Transfer Center (MHTTC) Network

Addiction as a Chronic Relapsing Disease: Managing Your Practice - PCSS - Wednesday, September 28, 2022 1:00 PM ET

Addiction as a Chronic Relapsing Disease: Managing Your Practice - PCSS

Recovery High Schools as a Protective Factor against the Progression of Substance Use & Co-Occurring Disorders—Webinar Wednesday, September 28, 2022 12:00 PM ET

Opioid Response Network

Models of Suicide Behavior and Ways to Mitigate Risk | Mental Health Technology Transfer Center (MHTTC) Network - Tuesday, September 27, 2022 4:00 PM ET

Models of Suicide Behavior and Ways to Mitigate Risk | Mental Health Technology Transfer Center (MHTTC) Network

Ethical Considerations for Clinical Investigations of Medical Products Involving Children | FDA

Ethical Considerations for Clinical Investigations of Medical Products Involving Children | FDA

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials | FDA

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials | FDA

NIMH Research Domain Criteria Roundtable - Data-Driven Refinement of Psychopathology: Toward Precision Diagnostics Date/Time: September 28, 2022, 12:00–5:00 p.m. ET Location: Virtual

Inscripción al seminario web - Zoom

Recognizing National Sickle Cell Awareness Month

Recognizing National Sickle Cell Awareness Month

viernes, 23 de septiembre de 2022

Exploration of a rapid response team model of care: a descriptive dual methods study. | PSNet

Exploration of a rapid response team model of care: a descriptive dual methods study. | PSNet

Pathology trainees rarely report safety incidents: a review of 13,722 safety reports and a call to action. | PSNet

Pathology trainees rarely report safety incidents: a review of 13,722 safety reports and a call to action. | PSNet

Opioid dependence and overdose after surgery: rate, risk factors, and reasons. | PSNet

Opioid dependence and overdose after surgery: rate, risk factors, and reasons. | PSNet

Sustained improvement in quality of patient handoffs after orthopaedic surgery I-PASS intervention. | PSNet

Sustained improvement in quality of patient handoffs after orthopaedic surgery I-PASS intervention. | PSNet

Frontiers in measuring structural racism and its health effects. | PSNet

Frontiers in measuring structural racism and its health effects. | PSNet

Deputy Attorney General’s Speech Highlights Changes in How DOJ Investigates and Prosecutes

Deputy Attorney General’s Speech Highlights Changes in How DOJ Investigates and Prosecutes

What’s New for Biologics | FDA

What’s New for Biologics | FDA

FDA Unveils Its Own Medical Queries—A Standardized Approach for Grouping MedDRA Preferred Terms that Will Impact NDA/BLA Safety Analyses and Drug Labeling

FDA Unveils Its Own Medical Queries—A Standardized Approach for Grouping MedDRA Preferred Terms that Will Impact NDA/BLA Safety Analyses and Drug Labeling

The Latest on the Biopharmaceutical Industry's Efforts to Beat Coronavirus | PhRMA

The Latest on the Biopharmaceutical Industry's Efforts to Beat Coronavirus | PhRMA

Partnerships are driving global COVID-19 treatment access

Partnerships are driving global COVID-19 treatment access

An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations - 10/26/2022 | FDA

An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations - 10/26/2022 | FDA

CDER Small Business & Industry Assistance (SBIA) | FDA

CDER Small Business & Industry Assistance (SBIA) | FDA

Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry | FDA

Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry | FDA

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

Más de 237 millones de errores de medicación por año en Inglaterra

Más de 237 millones de errores de medicación por año en Inglaterra

jueves, 22 de septiembre de 2022

Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry | FDA

Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry | FDA

What is a 340B covered entity?

What is a 340B covered entity?

​​​​​​​Global burden of type 1 diabetes likely to double by 2040, study predicts

​​​​​​​Global burden of type 1 diabetes likely to double by 2040, study predicts

Vizient recognizes NYU Langone Health as No. 1 in quality and safety for inpatient, ambulatory care

Vizient recognizes NYU Langone Health as No. 1 in quality and safety for inpatient, ambulatory care

How did the COVID-19 pandemic alter racial and ethnic disparities in mortality?

How did the COVID-19 pandemic alter racial and ethnic disparities in mortality?

No Walk in the Park: JAMA Editorial Calls for More Park Prosecutions; We Disagree

No Walk in the Park: JAMA Editorial Calls for More Park Prosecutions; We Disagree

Reinforcing the Value and Roles of Nurses in Diagnostic Safety: Pragmatic Recommendations for Nurse Leaders and Educators | Agency for Healthcare Research and Quality

Reinforcing the Value and Roles of Nurses in Diagnostic Safety: Pragmatic Recommendations for Nurse Leaders and Educators | Agency for Healthcare Research and Quality

Reducing Healthcare Carbon Emissions: A Primer on Measures and Actions for Healthcare Organizations to Mitigate Climate Change | Agency for Healthcare Research and Quality

Reducing Healthcare Carbon Emissions: A Primer on Measures and Actions for Healthcare Organizations to Mitigate Climate Change | Agency for Healthcare Research and Quality

AHRQ Releases Primer for Reducing Healthcare Carbon Emissions | Agency for Healthcare Research and Quality

AHRQ Releases Primer for Reducing Healthcare Carbon Emissions | Agency for Healthcare Research and Quality

An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations - 10/26/2022 | FDA

An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations - 10/26/2022 | FDA

Bioavailability Studies Submitted in NDAs or INDs

Bioavailability Studies Submitted in NDAs or INDs

Funding News

Funding News

Study Data Standards Update for CBER: Your Guide to a Successful Submission - 10/05/2022 | FDA

Study Data Standards Update for CBER: Your Guide to a Successful Submission - 10/05/2022 | FDA

CDER Small Business & Industry Assistance (SBIA) | FDA

CDER Small Business & Industry Assistance (SBIA) | FDA

2022 National Strategy to Support Family Caregivers | ACL Administration for Community Living

2022 National Strategy to Support Family Caregivers | ACL Administration for Community Living

What’s New for Biologics | FDA

What’s New for Biologics | FDA

SMDL_PDPM 22-005 FINAL CLEARED 9-20-22_dat

SMDL_PDPM 22-005 FINAL CLEARED 9-20-22_dat

White House Conference on Hunger, Nutrition, and Health | health.gov

White House Conference on Hunger, Nutrition, and Health | health.gov

miércoles, 21 de septiembre de 2022

World Alzheimer’s Day 2022: Improving Post-Diagnosis Care with COGNISANCE

World Alzheimer’s Day 2022: Improving Post-Diagnosis Care with COGNISANCE

How Using Contingency Management Can Support Families Affected by Substance Use Disorders Thursday, September 29, 2022 1:30 PM – 3:00 PM ET

Inscripción al seminario web - Zoom

NIH Collaboration Seeks to Help Understand U.S. Burden of Health Disparities: Why Your County Matters – NIH Director's Blog

NIH Collaboration Seeks to Help Understand U.S. Burden of Health Disparities: Why Your County Matters – NIH Director's Blog

Registration for AHRQ NRSA T32 Funding Opportunity Technical Assistance Call

Registration for AHRQ NRSA T32 Funding Opportunity Technical Assistance Call AHRQ Seeks Applicants for National Research Service Award Institutional Research Training Program AHRQ is seeking applications for its National Research Service Award (NRSA) Institutional Research Training Program. The NRSA program offers advanced training to predoctoral and postdoctoral fellows at eligible institutions with programs in health services research. AHRQ encourages all institutions, including minority-serving institutions, to apply for this T32 grant program. Letters of intent are due Oct. 14, and applications are due Dec. 1. Access more information. A technical assistance call is scheduled Oct. 5 from 1 to 2 p.m. ET. Registration is required.

RFA-HS-22-010: AHRQ National Research Service Award (NRSA) Institutional Research Training Grant (T32)

RFA-HS-22-010: AHRQ National Research Service Award (NRSA) Institutional Research Training Grant (T32)

Inclusion of nonrandomized studies of interventions in systematic reviews of interventions: Updated guidance from the Agency for Healthcare Research and Quality Effective Healthcare Program - Journal of Clinical Epidemiology

Inclusion of nonrandomized studies of interventions in systematic reviews of interventions: Updated guidance from the Agency for Healthcare Research and Quality Effective Healthcare Program - Journal of Clinical Epidemiology

Methods Guide for Effectiveness and Comparative Effectiveness Reviews | Effective Health Care (EHC) Program

Methods Guide for Effectiveness and Comparative Effectiveness Reviews | Effective Health Care (EHC) Program

Experience of learning from everyday work in daily safety huddles: a multi-method study. | PSNet

Experience of learning from everyday work in daily safety huddles: a multi-method study. | PSNet

Potentially inappropriate medication administration is associated with adverse postoperative outcomes in older surgical patients: a retrospective cohort study. | PSNet

Potentially inappropriate medication administration is associated with adverse postoperative outcomes in older surgical patients: a retrospective cohort study. | PSNet

The Psychological Safety Scale of the Safety, Communication, Operational, Reliability, and Engagement (SCORE) survey: a brief, diagnostic, and actionable metric for the ability to speak up in healthcare settings. | PSNet

The Psychological Safety Scale of the Safety, Communication, Operational, Reliability, and Engagement (SCORE) survey: a brief, diagnostic, and actionable metric for the ability to speak up in healthcare settings. | PSNet

Federal Register :: Request for Information on Person-Centered Care Planning for Multiple Chronic Conditions (MCC)

Federal Register :: Request for Information on Person-Centered Care Planning for Multiple Chronic Conditions (MCC) Input Sought on How To Support Better Care for People With Multiple Chronic Conditions AHRQ is requesting public comments to inform future planning and the agency’s research agenda to improve care for people at risk for, or living with, multiple chronic conditions (MCC). A Request for Information seeks input on the current state of shared, person-centered care planning for people with MCC, including insights into current and innovative models of shared care planning used in practice, scale of implementation, barriers and facilitators to implementation, and promising strategies and solutions to overcome implementation barriers. Input is sought on care models across a variety of care settings, including health systems, primary care, home and other ambulatory practices. Comments are due Nov. 15. Access the Request for Information for more information and submit responses to MCC@ahrq.hhs.gov.

QuestionBuilder en Español | Agency for Healthcare Research and Quality

QuestionBuilder en Español | Agency for Healthcare Research and Quality

Health Literacy | Agency for Healthcare Research and Quality

Health Literacy | Agency for Healthcare Research and Quality

Patient and Family Engagement | Agency for Healthcare Research and Quality

Patient and Family Engagement | Agency for Healthcare Research and Quality

Información en español | Agency for Healthcare Research and Quality

Información en español | Agency for Healthcare Research and Quality

Hispanic Heritage Month — Home

Hispanic Heritage Month — Home

Improving health equity through clinical innovation - PubMed

Improving health equity through clinical innovation - PubMed

Trajectories of prescription opioid dose and risk of opioid-related adverse events among older Medicare beneficiaries in the United States: A nested case-control study - PubMed

Trajectories of prescription opioid dose and risk of opioid-related adverse events among older Medicare beneficiaries in the United States: A nested case-control study - PubMed

Analysis of Hospital-Level Readmission Rates and Variation in Adverse Events Among Patients With Pneumonia in the United States - PubMed

Analysis of Hospital-Level Readmission Rates and Variation in Adverse Events Among Patients With Pneumonia in the United States - PubMed

Measure Dx: Implementing pathways to discover and learn from diagnostic errors - PubMed

Measure Dx: Implementing pathways to discover and learn from diagnostic errors - PubMed

Measure Dx: A Resource To Identify, Analyze, and Learn From Diagnostic Safety Events | Agency for Healthcare Research and Quality

Measure Dx: A Resource To Identify, Analyze, and Learn From Diagnostic Safety Events | Agency for Healthcare Research and Quality

Physician Compensation Arrangements and Financial Performance Incentives in US Health Systems - PubMed

Physician Compensation Arrangements and Financial Performance Incentives in US Health Systems - PubMed

Risk of Metabolic and Cardiovascular Adverse Events With Abiraterone or Enzalutamide Among Men With Advanced Prostate Cancer - PubMed

Risk of Metabolic and Cardiovascular Adverse Events With Abiraterone or Enzalutamide Among Men With Advanced Prostate Cancer - PubMed

Change in worry over time among Hispanic women with thyroid cancer - PubMed

Change in worry over time among Hispanic women with thyroid cancer - PubMed

The association of health literacy and postoperative complications after colorectal surgery: A cohort study - PubMed

The association of health literacy and postoperative complications after colorectal surgery: A cohort study - PubMed

Understanding the surgical experience for Black and White patients with inflammatory bowel disease (IBD): The importance of health literacy - PubMed

Understanding the surgical experience for Black and White patients with inflammatory bowel disease (IBD): The importance of health literacy - PubMed

STATISTICAL BRIEF #540: Concentration of Healthcare Expenditures and Selected Characteristics of Persons with High Expenses, U.S. Civilian Noninstitutionalized Population, 2019

STATISTICAL BRIEF #540: Concentration of Healthcare Expenditures and Selected Characteristics of Persons with High Expenses, U.S. Civilian Noninstitutionalized Population, 2019

Electronic Submission Template for Medical Device 510(k) Submissions | FDA

Electronic Submission Template for Medical Device 510(k) Submissions | FDA

FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines – September 27, 2022 | FDA

FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines – September 27, 2022 | FDA

Opportunity for Public Comment | United States Preventive Services Taskforce: Public Comment on Draft Recommendation Statement and Draft Evidence Review: Screening for Depression and Suicide Risk in Adults

Opportunity for Public Comment | United States Preventive Services Taskforce

Opportunity for Public Comment | United States Preventive Services Taskforce: Public Comment on Draft Recommendation Statement and Draft Evidence Review: Screening for Anxiety in Adults

Opportunity for Public Comment | United States Preventive Services Taskforce

CDER Conversation: OGD Global Affairs Program, One Year Progress Report of Generic Drug Cluster | FDA

CDER Conversation: OGD Global Affairs Program, One Year Progress Report of Generic Drug Cluster | FDA

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

What’s New for Biologics | FDA

What’s New for Biologics | FDA

FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 Approach

FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 Approach

FDA Monkeypox Response | FDA

FDA Monkeypox Response | FDA

Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Outbreak | Monkeypox | Poxvirus | CDC

Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Outbreak | Monkeypox | Poxvirus | CDC

Virtual Town Hall Series - Monkeypox Test Development and Validation - 09/21/2022 | FDA

Virtual Town Hall Series - Monkeypox Test Development and Validation - 09/21/2022 | FDA

martes, 20 de septiembre de 2022

Monkeypox infection in a smallpox-vaccinated patient

Monkeypox infection in a smallpox-vaccinated patient

The potential of nanobody engineering in the development of SARS-CoV-2 antivirals and diagnostic tools

The potential of nanobody engineering in the development of SARS-CoV-2 antivirals and diagnostic tools

Clearing pollution helps clear the fog of aging — and may cut the risk of dementia

Clearing pollution helps clear the fog of aging — and may cut the risk of dementia

What are the 2-year health outcomes among patients hospitalized for COVID-19 in China?

What are the 2-year health outcomes among patients hospitalized for COVID-19 in China?

What is the SARS-CoV-2 transmissibility among United States residents?

What is the SARS-CoV-2 transmissibility among United States residents?

Healthcare systems seem may be ill-equipped to handle high co-circulation of influenza and SARS-CoV-2 in the coming year

Healthcare systems seem may be ill-equipped to handle high co-circulation of influenza and SARS-CoV-2 in the coming year

Virtual Town Hall Series - Monkeypox Test Development and Validation - 09/21/2022 | FDA

Virtual Town Hall Series - Monkeypox Test Development and Validation - 09/21/2022 | FDA

Clinical Trials Transformation Initiative - CTTI

Clinical Trials Transformation Initiative - CTTI

Federal Register :: Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative

Federal Register :: Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative

Patient Engagement Collaborative | FDA

Patient Engagement Collaborative | FDA

PEC Application Form 2022

PEC Application Form 2022

What’s New for Biologics | FDA

What’s New for Biologics | FDA

Prostate Cancer: Tuesday, October 4, 2022, 1 p.m. – 4 p.m. ET

Inscripción al seminario web - Zoom

Rheumatoid Arthritis: Friday, September 30, 2022, 1 p.m. – 4 p.m. ET

Inscripción al seminario web - Zoom

Kidney Transplant Management: Thursday, September 29, 2022, 11 a.m. – 2 p.m. ET

Inscripción al seminario web - Zoom

Reducing Patient Falls with Evidence-based Tools | Agency for Healthcare Research and Quality

Reducing Patient Falls with Evidence-based Tools | Agency for Healthcare Research and Quality

COVID-19 Noticias / Opiniones CHEQUEADAS EN INGLÉS y otros idiomas

COVID-19 Noticias / Opiniones CHEQUEADAS EN INGLÉS y otros idiomas

Complexity of Covid vaccine program fuels concern on potential for errors

Complexity of Covid vaccine program fuels concern on potential for errors

Behind the 'world's friendliest COVID protocols,' Fiji's health system remains stretched and struggling

Behind the 'world's friendliest COVID protocols,' Fiji's health system remains stretched and struggling

COVID-19 Informes Científicos CHEQUEADOS COMPLETOS REVISADOS (full texts)

COVID-19 Informes Científicos CHEQUEADOS COMPLETOS REVISADOS (full texts)

Environmental SARS-CoV-2 contamination in hospital rooms of patients with acute COVID-19 - ScienceDirect

Environmental SARS-CoV-2 contamination in hospital rooms of patients with acute COVID-19 - ScienceDirect

Indice General de Autoevaluaciones

Indice General de Autoevaluaciones

Novedades COVID-19

Novedades COVID-19

COVID-19 ESPECIALISTAS opinan Expertos Invitados (Castellano)

COVID-19 ESPECIALISTAS opinan Expertos Invitados (Castellano)

TRATAMIENTOS FARMACOLÓGICOS PARA COVID-19

TRATAMIENTOS FARMACOLÓGICOS PARA COVID-19

COVID-19 Noticias / Opiniones CHEQUEADAS

COVID-19 Noticias / Opiniones CHEQUEADAS

lunes, 19 de septiembre de 2022

STEM | PhRMA

STEM | PhRMA

Closing the Gender Gap in Innovation: The Biopharmaceutical Industry Leads the Way | PhRMA

Closing the Gender Gap in Innovation: The Biopharmaceutical Industry Leads the Way | PhRMA

Intellectual Property waiver on COVID-19 innovation is unnecessary and harmful

Intellectual Property waiver on COVID-19 innovation is unnecessary and harmful

The dangers of expanding the TRIPS waiver

The dangers of expanding the TRIPS waiver

Webinar: SAMHSA Office of Behavioral Health Equity Recovery Month Thursday, September 22, 2022 1:30 PM – 3:00 PM ET

Iniciar reunión - Zoom Webinar: SAMHSA Office of Behavioral Health Equity Recovery Month Thursday, September 22, 2022 1:30 PM – 3:00 PM ET The purpose of this webinar will be to discuss the need for behavioral health equity to ensure individuals living in underserved communities have access to recovery, treatment, and support. Join us as our presenter, Dr. Victoria Cargill, will discuss: The impact of discrimination, racism, and racial trauma on marginalized individuals living with substance use disorders; Intersecting effects of the social determinants of health; Effective and successful interventions that support substance use disorder treatment for underserved populations; Barriers to equitable treatment, recovery, and support services; and How we move forward together as a nation. Please click the link below to join the webinar: https://www.zoomgov.com/j/1614017737?pwd=RjNHcW9SWmR1RVJqRW10bFlJQ0hYZz09 Webinar ID: 161 401 7737. Passcode: 393593 Or One tap mobile : US: +16468287666,,1614017737#,,,,*393593# or +15512851373,,1614017737#,,,,*393593# Or Telephone: US: +1 646 828 7666 or +1 551 285 1373 Presenter: Headshot of Dr. Cargill Victoria Cargill, MD, MSCE IAS-USE Assistant Commissioner, Baltimore City Health Department Dr. Victoria Cargill is a Boston and Harvard University trained board-certified internal medicine and HIV physician, and former Assistant Commissioner of Health at the Baltimore City Health Department, overseeing the Ryan White program and Community Risk Reduction/Syringe Support Services. Prior to becoming an Assistant Commissioner, she served as a senior policy analyst and program director for 20 years at the National Institutes of Health (NIH) in both the Office of AIDS Research (OAR) and the Office of Research on Women’s Health (ORWH). At OAR, she was the Director of Minority Research and Clinical Studies, and Acting Director of HIV Therapeutics Research. At ORWH, she served as the Associate Director for Interdisciplinary Research, and grew the U3 program focused on stimulating research on understudied, underreported, and underrepresented women to over $3 million dollars. She has also served as the acting chair of the FDA Antiviral Advisory Committee, including chairing the hearings of the first two U.S.-approved HCV antivirals. A former co-investigator at the Case Western AIDS Clinical Trials Unit and the creator of an AIDS education and prevention adolescent-focused program that reached over 100,000 teens in five Ohio cities, she has extensive public health and HIV prevention research experience. Currently the principal investigator of a HRSA-funded Ending the HIV Epidemic grant, and the author of over 150 scientific articles, research presentations, book chapters and popular press educational materials, she has been nationally recognized as one of America’s Top Doctors. Dr. Cargill continues to consider patients and communities as her best teachers.

Journal of Medical Case Reports | Home page

Journal of Medical Case Reports | Home page

Journal of Occupational Medicine and Toxicology | Home page

Journal of Occupational Medicine and Toxicology | Home page

One Health Outlook | Home

One Health Outlook | Home

Population Health Metrics | Home page

Population Health Metrics | Home page

Journal of Pharmaceutical Policy and Practice | Home page

Journal of Pharmaceutical Policy and Practice | Home page

BMC Medical Ethics | Home page

BMC Medical Ethics | Home page

Journal of Pharmaceutical Health Care and Sciences | Home page

Journal of Pharmaceutical Health Care and Sciences | Home page

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

Federal Register :: Medicare Program; Suspension of Required Prior Authorization for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items Under Certain Circumstances

Federal Register :: Medicare Program; Suspension of Required Prior Authorization for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items Under Certain Circumstances

NOT-HS-22-023: Notice of Pre-Application Technical Assistance Webinar for RFA-HS-22-010 AHRQ National Research Service Award (NRSA) Institutional Research Training Grant (T32)

NOT-HS-22-023: Notice of Pre-Application Technical Assistance Webinar for RFA-HS-22-010 AHRQ National Research Service Award (NRSA) Institutional Research Training Grant (T32)

Focusing on Patients to Reduce Healthcare-Associated Infections During Transitions to Home Care | Agency for Healthcare Research and Quality

Focusing on Patients to Reduce Healthcare-Associated Infections During Transitions to Home Care | Agency for Healthcare Research and Quality

Reducing Patient Falls with Evidence-based Tools | Agency for Healthcare Research and Quality

Reducing Patient Falls with Evidence-based Tools | Agency for Healthcare Research and Quality

domingo, 18 de septiembre de 2022

Focusing on Patients to Reduce Healthcare-Associated Infections During Transitions to Home Care | Agency for Healthcare Research and Quality

Focusing on Patients to Reduce Healthcare-Associated Infections During Transitions to Home Care | Agency for Healthcare Research and Quality

Specific PHGKB|Pharmacogenomics PHGKB|PHGKB

Specific PHGKB|Pharmacogenomics PHGKB|PHGKB

Specific PHGKB|Neurological Disorders PHGKB|PHGKB

Specific PHGKB|Neurological Disorders PHGKB|PHGKB

Specific PHGKB|Infectious Diseases|PHGKB

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Specific PHGKB|Health Equity PHGKB|PHGKB

Specific PHGKB|Health Equity PHGKB|PHGKB

Specific PHGKB|Environmental Health PHGKB|PHGKB

Specific PHGKB|Environmental Health PHGKB|PHGKB

CDC-Authored Publications Update|PHGKB

CDC-Authored Publications Update|PHGKB

Precision Health Database| Non-Genomics Precision Health Weekly Scan|PHGKB

Precision Health Database| Non-Genomics Precision Health Weekly Scan|PHGKB

Advanced Molecular Detection Clips Database|AMD Clips|PHGKB

Advanced Molecular Detection Clips Database|AMD Clips|PHGKB

Precision Health Database| Genomics Precision Health Weekly Scan|PHGKB

Precision Health Database| Genomics Precision Health Weekly Scan|PHGKB

Public Health Genomics | CDC

Public Health Genomics | CDC

2022 Human Genomics and Public Health Fellowship Program | CDC

2022 Human Genomics and Public Health Fellowship Program | CDC

Genomics, Health Equity, and Global Health | Blogs | CDC

Genomics, Health Equity, and Global Health | Blogs | CDC

Annual Conference: National Society of Genetic Counselors 41st Annual Conference November 16-20 – Nashville, TN

Annual Conference

Home - RNA at the Bench and Bedside III - November 8, 2022 – November 10, 2022 8:00 AM-5:00 PMPT

Home - RNA at the Bench and Bedside III

2022 Annual Meeting - ASHG - American Society of Human Genetics Annual Meeting October 25-29 – Los Angeles, CA

2022 Annual Meeting - ASHG

Coronary Heart Disease, Family History and Public Health: From Familial Hypercholesterolemia to Elevated Lipoprotein A | CDC - October 24, 2022, 1:00 pm -2:00 pm ET

Coronary Heart Disease, Family History and Public Health: From Familial Hypercholesterolemia to Elevated Lipoprotein A | CDC

Host Genomics and COVID-19: Implications for Clinical and Public Health Practice | CDC - October 6, 2022, 11:00 am -12:00 noon ET

Host Genomics and COVID-19: Implications for Clinical and Public Health Practice | CDC

From All of Us Research to All of Us in the Real World: Using the All of Us Research Program Data to Improve Population Health | CDC - September 29, 9:30-11:00 am, EDT

From All of Us Research to All of Us in the Real World: Using the All of Us Research Program Data to Improve Population Health | CDC

sábado, 17 de septiembre de 2022

Donated COVID drugs start flowing to poor nations — but can’t meet demand

Donated COVID drugs start flowing to poor nations — but can’t meet demand

Patient Safety and Quality Improvement | Agency for Healthcare Research and Quality

Patient Safety and Quality Improvement | Agency for Healthcare Research and Quality

MEDICOS 122 - EDICIÓN DIGITAL - SETIEMBRE 2022

MEDICOS 122

NIMH » Suicide Prevention Research in a Rapidly Changing World

NIMH » Suicide Prevention Research in a Rapidly Changing World

World Patient Safety Day Focuses on Medication Safety

World Patient Safety Day Focuses on Medication Safety

Drug Approval Package: TPOXX (tecovirimat)

Drug Approval Package: TPOXX (tecovirimat)

FDA Monkeypox Response | FDA

FDA Monkeypox Response | FDA

Study finds key differences in COVID-19 vaccination rates by race, ethnicity and borough at NYC schools

Study finds key differences in COVID-19 vaccination rates by race, ethnicity and borough at NYC schools

NYU Langone Hospital—Brooklyn receives first Magnet recognition for excellence in nursing

NYU Langone Hospital—Brooklyn receives first Magnet recognition for excellence in nursing

Moral values determine COVID vaccination acceptance rates in the United States

Moral values determine COVID vaccination acceptance rates in the United States

FAU researchers explore the impacts of COVID-19 pandemic on resident physicians

FAU researchers explore the impacts of COVID-19 pandemic on resident physicians

New abortion laws jeopardize cancer treatment for pregnant patients

New abortion laws jeopardize cancer treatment for pregnant patients

Survey reveals the impact of COVID-19 on Australian women’s health and fitness

Survey reveals the impact of COVID-19 on Australian women’s health and fitness

Genomic sequencing reveals the course of COVID-19 in Africa

Genomic sequencing reveals the course of COVID-19 in Africa

New LSHTM Press seeks to improve health equity in the UK and worldwide

New LSHTM Press seeks to improve health equity in the UK and worldwide

Antibody drugs are not recommended for patients with covid-19, say WHO experts

Antibody drugs are not recommended for patients with covid-19, say WHO experts

UW Medicine researchers seek participants for Phase 3 clinical trial of a drug to treat monkeypox

UW Medicine researchers seek participants for Phase 3 clinical trial of a drug to treat monkeypox

Webinar Series: Accelerating Healthcare Sector Action on Climate Change and Health Equity | HHS.gov

Webinar Series: Accelerating Healthcare Sector Action on Climate Change and Health Equity | HHS.gov

USP FDA Biosimilars Infographic_FDA_V8

USP FDA Biosimilars Infographic_FDA_V8

viernes, 16 de septiembre de 2022

President Biden Issues Executive Order to Boost Federal Investment in Domestic Biotechnology and Biomanufacturing

President Biden Issues Executive Order to Boost Federal Investment in Domestic Biotechnology and Biomanufacturing

AACR Conference: Cancer Health Disparities | AACR Meetings

AACR Conference: Cancer Health Disparities | AACR Meetings

Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned

Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned

MCBS Data Highlight on Utilization of Dental, Vision and Hearing Care Services in 2019 | CMS

MCBS Data Highlight on Utilization of Dental, Vision and Hearing Care Services in 2019 | CMS

Medicare Telehealth Trends - Centers for Medicare & Medicaid Services Data

Medicare Telehealth Trends - Centers for Medicare & Medicaid Services Data

Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches - 11/09/2022 | FDA

Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches - 11/09/2022 | FDA

What’s New for Biologics | FDA

What’s New for Biologics | FDA

NCI Annual Plan & Budget Proposal for Fiscal Year 2024 - NCI

NCI Annual Plan & Budget Proposal for Fiscal Year 2024 - NCI

President Biden Delivers Remarks on the Cancer Moonshot and the Goal of ...

NCTR Research Highlights | FDA

NCTR Research Highlights | FDA FDA NanoDay Symposium 2022 — Register for the Free Event The Center for Drug Evaluation and Research’s Small Business and Industry Assistance (CDER SBIA) group will host the FDA NanoDay Symposium 2022 on October 11th from 8:50 AM to 3:10 PM EASTERN. This event is free to the public, but registration is required. Dr. Anil Patri, NCTR Nanocore Director and chair of the FDA Nanotechnology Task Force, will present the welcome message and discuss nanomaterial standards development at FDA. Dr. Patri will also participate in the Question & Answer panel at the end of the symposium. For event information, including the agenda and virtual attendance, please visit FDA NanoDay Symposium 2022.

What is a 340B covered entity?

What is a 340B covered entity?

AIR340B_LeftBehind_2022.pdf

AIR340B_LeftBehind_2022.pdf

Drug Channels: The 340B Program Climbed to $44 Billion in 2021—With Hospitals Grabbing Most of the Money

Drug Channels: The 340B Program Climbed to $44 Billion in 2021—With Hospitals Grabbing Most of the Money

New data: The 340B program is driving up costs for patients and our health care system

New data: The 340B program is driving up costs for patients and our health care system

jueves, 15 de septiembre de 2022

A Recipe for Danger: Social Media Challenges Involving Medicines | FDA

A Recipe for Danger: Social Media Challenges Involving Medicines | FDA

Experience of learning from everyday work in daily safety huddles: a multi-method study. | PSNet

Experience of learning from everyday work in daily safety huddles: a multi-method study. | PSNet

Potentially inappropriate medication administration is associated with adverse postoperative outcomes in older surgical patients: a retrospective cohort study. | PSNet

Potentially inappropriate medication administration is associated with adverse postoperative outcomes in older surgical patients: a retrospective cohort study. | PSNet

The Psychological Safety Scale of the Safety, Communication, Operational, Reliability, and Engagement (SCORE) survey: a brief, diagnostic, and actionable metric for the ability to speak up in healthcare settings. | PSNet

The Psychological Safety Scale of the Safety, Communication, Operational, Reliability, and Engagement (SCORE) survey: a brief, diagnostic, and actionable metric for the ability to speak up in healthcare settings. | PSNet

Analysis of Requirements for Coverage with Evidence Development (CED) – Topic Refinement | Effective Health Care (EHC) Program

Analysis of Requirements for Coverage with Evidence Development (CED) – Topic Refinement | Effective Health Care (EHC) Program

Court ruling may spur competitive health plans to bring back copays for preventive services

Court ruling may spur competitive health plans to bring back copays for preventive services

Montana health department seeks to ax board that hears public assistance appeals

Montana health department seeks to ax board that hears public assistance appeals

Doctors experiencing burnout can jeopardize the quality and safety of patient care

Doctors experiencing burnout can jeopardize the quality and safety of patient care

Advancing Generic Drug Development: Translating Science to Approval - 09/20/2022 | FDA

Advancing Generic Drug Development: Translating Science to Approval - 09/20/2022 | FDA

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

Telemedicina en Latinoamérica: retos y vacíos legales

Telemedicina en Latinoamérica: retos y vacíos legales

Bridging Our Way to Health Restoration | NCCIH

Bridging Our Way to Health Restoration | NCCIH

FDA Grand Rounds | FDA - Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins

FDA Grand Rounds | FDA

FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases | FDA

FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases | FDA

What’s New for Biologics | FDA

What’s New for Biologics | FDA

Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products

Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products

FDA Publishes Two Draft Guidances Addressing Non-prescription Drugs Labels

FDA Publishes Two Draft Guidances Addressing Non-prescription Drugs Labels

miércoles, 14 de septiembre de 2022

National Science Advisory Board for Biosecurity to meet | National Institutes of Health (NIH)

National Science Advisory Board for Biosecurity to meet | National Institutes of Health (NIH)

What’s New for Biologics | FDA

What’s New for Biologics | FDA

RDCA-DAP | Critical Path Institute

RDCA-DAP | Critical Path Institute FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases. The FDA and NIH have selected the Critical Path InstituteExternal Link Disclaimer (C-Path) as the convener of this partnership. “There is a crucial need to develop new treatments that can improve and extend the lives of people diagnosed with rare neurodegenerative diseases, including ALS. Collaboration across public and private sectors can accelerate the progress to address this urgent need,” said FDA Chief Medical Officer, Hilary Marston, M.D., M.P.H. “The partnership we are announcing today will leverage the shared expertise of all participants to create a path towards new breakthroughs in treating these diseases. We look forward to working with NIH, C-Path, and other public and private partners to carry out this important effort.” “This public-private partnership will convene the entire ALS community to develop novel strategies and approaches to therapy development and clinical testing with the goal to finally produce a treatment that stops the tragic progression of ALS,” said Walter Koroshetz, M.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH. C-Path will convene the partnership, bringing together experts in rare neurodegenerative diseases, including, but not limited to, patient communities, advocacy organizations, and private entities. The direction and priorities for the effort will be determined with input from the partners. Areas of focus will include patient-focused drug development, and utilization of the FDA-funded Rare Disease Cures Accelerator-Data and Analytics PlatformExternal Link Disclaimer (RDCA-DAP) to bring together scientific data on rare neurodegenerative diseases to facilitate the characterization of neurodegenerative diseases and their natural history, the identification of molecular targets for neurodegenerative disease, and increased efficiency, predictability, and productivity of clinical development of therapies. Building on and leveraging the shared expertise of the participants, the goal of this partnership is to generate actionable solutions that can tangibly accelerate drug development for rare neurodegenerative diseases. The Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (Act for ALS) was signed into law on December 23, 2021 by President Biden and requires HHS, through FDA and NIH, to establish and implement a public-private partnership not later than one year after enactment. This partnership is a key component of the FDA’s Action Plan announced in June. To learn more about the Critical Path for Rare Neurodegenerative Diseases, contact the C-Path team at CP-RND@cpath.org.

Critical Path Institute

Critical Path Institute FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases. The FDA and NIH have selected the Critical Path InstituteExternal Link Disclaimer (C-Path) as the convener of this partnership. “There is a crucial need to develop new treatments that can improve and extend the lives of people diagnosed with rare neurodegenerative diseases, including ALS. Collaboration across public and private sectors can accelerate the progress to address this urgent need,” said FDA Chief Medical Officer, Hilary Marston, M.D., M.P.H. “The partnership we are announcing today will leverage the shared expertise of all participants to create a path towards new breakthroughs in treating these diseases. We look forward to working with NIH, C-Path, and other public and private partners to carry out this important effort.” “This public-private partnership will convene the entire ALS community to develop novel strategies and approaches to therapy development and clinical testing with the goal to finally produce a treatment that stops the tragic progression of ALS,” said Walter Koroshetz, M.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH. C-Path will convene the partnership, bringing together experts in rare neurodegenerative diseases, including, but not limited to, patient communities, advocacy organizations, and private entities. The direction and priorities for the effort will be determined with input from the partners. Areas of focus will include patient-focused drug development, and utilization of the FDA-funded Rare Disease Cures Accelerator-Data and Analytics PlatformExternal Link Disclaimer (RDCA-DAP) to bring together scientific data on rare neurodegenerative diseases to facilitate the characterization of neurodegenerative diseases and their natural history, the identification of molecular targets for neurodegenerative disease, and increased efficiency, predictability, and productivity of clinical development of therapies. Building on and leveraging the shared expertise of the participants, the goal of this partnership is to generate actionable solutions that can tangibly accelerate drug development for rare neurodegenerative diseases. The Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (Act for ALS) was signed into law on December 23, 2021 by President Biden and requires HHS, through FDA and NIH, to establish and implement a public-private partnership not later than one year after enactment. This partnership is a key component of the FDA’s Action Plan announced in June. To learn more about the Critical Path for Rare Neurodegenerative Diseases, contact the C-Path team at CP-RND@cpath.org.

Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches - 11/09/2022 | FDA

Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches - 11/09/2022 | FDA FDA and M-CERSI Announce a Virtual Public Workshop on Bridging Drug Efficacy and Safety to Obese Patients On November 9, 2022, the U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will hold a virtual public workshop entitled "Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches." The purpose of this workshop is to review the implications of obesity in adult and pediatric patients on safety, efficacy, drug dosing and disposition. Besides the major health and socioeconomic implications of obesity, there are great challenges in ensuring the optimal use and development of drugs for the growing population of obese persons. Obese patients are a large segment of the U.S. population and should be included in drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. Although smaller clinical studies have begun to examine drug pharmacokinetics in obese pediatric patients, the relationship between pediatric obesity and drug response, including efficacy and safety, has not been thoroughly elucidated. Advancing this field requires identifying key knowledge gaps and barriers to the conduct of such studies and potential innovative solutions to improve data generation and analysis. Workshop Objectives: Review the implications of obesity in adult and pediatric patients on safety, efficacy, drug dosing and disposition. Discuss: If adult and pediatric patients should be identified and studied as a special population in new drug development programs, and when it may be appropriate to include obese patients in drug development studies to develop specific dosing guidelines for obese patients. Date/Time of the Workshop: Date: November 9, 2022 Time: 8:30 a.m. – 4:15 p.m. This virtual workshop is open to the public; however, registration is required at: https://bioeumd.wufoo.com/forms/m16xw7q80ra8tsz/. More information about this event can be found at: https://www.fda.gov/drugs/news-events-human-drugs/bridging-efficacy-and-safety-obese-considerations-and-scientific-approaches-11092022.