FDA Updates for Health Professionals

• ANNOUNCEMENTS
• OPPORTUNITIES FOR COMMENT / GUIDANCES
• PRODUCT APPROVALS & CLEARANCES
• PRODUCT SAFETY
• UPCOMING MEETINGS
• RESOURCES

ANNOUNCEMENTS

The Unique Voices of Our Patient Representatives The patient representative program has existed since 1999 and is integral to fulfilling FDA’s strong commitment to ensure that the needs and choices of patients – as well as their families, caregivers, and advocates – are incorporated in ever greater ways in the work we do. The training that patient representatives receive helps prepare them to serve on FDA advisory committees, meetings and workshops, where they are knowledgeable about what it is like to cope with their disease – including such topics as side effects from treatments and important lifestyle issues. They also provide valuable contributions as consultants to our review staff. More information

The Future of Cardiovascular Medicine From the Regulatory Perspective In a recent article in the Journal of the American College of Cardiology, FDA Commissioner Robert Califf discusses improvement in cardiovascular outcomes. The partnerships between the FDA and multiple communities of stakeholders have successfully reduced death and disability from cardiovascular disease. Now, ingenious research and technology development, combined with general advances in biological and information technologies, will further accelerate improvement in outcomes. But if we are to harness these technologies and apply them effectively, our systems for evidence generation and healthcare delivery must continue to improve in concert with drugs, devices, and biological products. More information

FDA Working to Keep the U.S. Blood Supply Safe from Zika and other Emerging Threats (FDAVoice Blog)

When it became apparent early in 2016 that Zika virus could pose a risk to the blood supply in the United States, FDA issued recommendations to reduce the risk of its transmission through blood transfusions by deferring those donors at risk of being infected with Zika virus as well as by screening donated blood in certain areas. Given the large amount of scientific data that is emerging and the rapid spread of the outbreak in the Western hemisphere, FDA understands that it may need to revisit and update this guidance soon to maintain the safety of the blood supply. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting The committees will discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees will also discuss the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made on or before September 21, 2016. More information

Guidance for Industry: Insanitary Conditions at Compounding Facilities

FDA issued this guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions. This guidance is also intended to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health.This guidance document specifically addresses pharmacies, Federal facilities, physicians’ offices (including veterinarians’ offices), and outsourcing facilities that compound or repackage human or animal drugs (including radiopharmaceuticals); or that mix, dilute, or repackage biological products.More information 

PRODUCT APPROVALS & CLEARANCES

FDA approves Adlyxin to treat type 2 diabetes Adlyxin is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. Adlyxin was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin. Use of Adlyxin improved hemoglobin A1c levels (a measure of blood sugar levels) in these trials. More information

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed

PRODUCT SAFETY

Need Safety Information? For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination 

Use of B. cepacia contaminated product could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. More information

0.25 % Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter

Hospira, Inc., is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. In the event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. More information

VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall - Potential Valve Leakage

Dräger discovered that the check valve on the circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels. This can lead to serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death. More information

Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter

Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected. More Information

Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination

Sage Products initiated a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and health care facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening. More information

AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown

Ventilator recalled because of a faulty fuse on the alarm board, which may cause the ventilator to unexpectedly shut down. If the ventilator shuts down, a patient may not receive necessary oxygen.  More information

UPCOMING MEETINGS

FDA advisory committee meetings are free and open to the public.  No prior registration is required to attend.  Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.

Other types of meetings listed may require prior registration and fees.  Click on "more information" for details about each meeting. 

Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (Aug 10)

The committee will discuss, make recommendations, and vote on information regarding a de novo request for the SEEKER Newborn Screening System (SEEKER System), by Baebies, Inc.  The SEEKER System consists of the SEEKER Analyzer, the SEEKER 4-Plex Assay Kit, the SEEKER Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens. More information

Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting (Aug 16)

The committee will discuss and make recommendations regarding the appropriateness of clearing or approving of over-the-counter (OTC) diagnostic tests for the detection of pathogens causing infectious diseases, focusing on respiratory and sexually transmitted infections (STI).  Currently, there are no OTC diagnostic tests for infectious diseases cleared or approved by CDRH.  The committee will evaluate the risks and benefits to individual patients and to public health associated with clearing or approving OTC diagnostic tests for infectious diseases. More information

Public Workshop: Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c) (Aug 29)

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled “Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).” The purpose of this public workshop is to have a forum for dialogue with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm for antidiabetic drug therapies addresses the needs of patients with diabetes and to identify additional outcomes, beyond HbA1c, that are of direct relevance and importance to patients living with the disease. More information

Public Workshop; Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval (Sep 8)

The Food and Drug Administration is announcing a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” More information

Pediatric Clinical Investigator Training; Public Workshop (Sep 12 & 13)

The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. More information

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee and the Pediatric Advisory Committee (Sep 15 & 16)

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation. More information

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (Sept 20-21)

The Committee will discuss and make recommendations regarding the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. The meeting will be open to the public. FDA is establishing a docket for public comment. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

Comunicaciones de la FDA sobre la seguridad de los medicamentos en español

Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible  para proporcionar  versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov. Comunicaciones de la FDA

MedWatchLearn - Practice Reporting to FDA! This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA.More information

FDA Expert Commentary and Interview Series on Medscape

As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information  

Cardiovascular and Endocrine Liaison Program The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information

FDA Basics Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information FDA Voice FDA voice is the official blog from FDA's senior leadership and staff.More information

Medical Product Safety Network (Medsun)

Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.  The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety.  More information