sábado, 4 de abril de 2020

What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 4/3/2020




4/3/2020Investigational COVID-19 Convalescent Plasma - Emergency INDs
4/3/2020March 30, 2020 Summary Basis for Regulatory Action - DG Gel 8 ABO/Rh (2D)
4/3/2020Regenerative Medicine Advanced Therapy Designation
4/3/2020April 1, 2020 Untitled Letter - Dynamic Stem Cell Therapy
4/2/2020Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry
4/2/2020Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry
4/2/2020Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
4/2/2020Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
4/2/2020Expiration Date Extension for Anavip [Crotalidae Immune F(ab’)2 (Equine)]: Lot B-8G-33 through July 31, 2021; Lot B-9B-33 through February 28, 2022; and Lot B-9E-35 through June 30, 2022
4/2/2020Complete List of Licensed Products and Establishments
4/2/2020Complete List of Substantially Equivalent 510(k) Device Applications
4/2/2020Complete List of Currently Approved Premarket Approvals (PMAs)
4/2/2020Complete List of Currently Approved NDA and ANDA Application Submissions
4/1/2020Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the Coronavirus Disease 2019 Pandemic
4/1/2020CBER Vacancy: Staff Fellow – Bioinformatics (Individualized Cell and Gene Therapies)
4/1/2020April 1, 2020 Approval Letter -SEVENFACT
4/1/2020April 1, 2020 Approval Letter - Fluzone Quadrivalent
4/1/2020March 30 Approval Letter - DG Gel 8 ABO/Rh (2D)
3/27/2020Letter to Sponsors, Applicants and Regulated Entities on COVID-19
3/27/2020Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human Clinical Trials with SARS-CoV-2 Vaccines
3/26/2020Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions
3/26/20202020 Biological License Application Supplement Noteworthy Approvals
3/26/20202020 Biological Device Application Approvals
3/26/2020TRG Rapid Inquiry Program (TRIP)
3/24/2020March 23, 2020 Approval Letter - VAXELIS
3/24/2020Investigational COVID-19 Convalescent Plasma - Emergency INDs
3/23/2020March 20, 2020 Approval Letter - Typhim Vi
3/23/2020Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
3/20/2020March 20, 2020 Approval Letter - Fluarix Quadrivalent
3/19/2020Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic
3/18/2020Complete List of Donor Screening Assay for Infectious Agents and HIV Diagnostic Assays
3/18/2020March 13, 2020 Approval Letter - ALBAclone BL 125304-69 et al.
3/18/2020March 13, 2020 Approval Letter - ALBAclone STN#125309-64
3/16/2020eSubmitter Application History
3/16/2020Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement
3/13/2020Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
3/13/2020BK190430 - Anti-D Donor Management and Inventory System (ADIMS)
3/13/2020BK190421 - Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports
3/13/2020CBER-Regulated Products: Resolved Shortages
3/12/2020Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes
3/12/2020Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
3/12/2020Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry
3/11/2020Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak
3/11/2020BK190434 - ORTHO CONNECT 3.0
3/11/2020Regulatory Submissions - Electronic and Paper

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