The latest from FDA

Public health emergency response and other updates from FDA since our last MCMi email include: Updates on Highly Pathogenic Avian Influenza (HPAI) (also see information below) May 31, 2024: FDA approved mRESVIA (Respiratory Syncytial Virus Vaccine) for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. mRESVIA is an mRNA-based vaccine that is manufactured by ModernaTX, Inc. May 30, 2024: Q&A with FDA Podcast - The Role of Artificial Intelligence in Clinical Trial Design and Research with Dr. ElZarrad May 29, 2024: FDA notified selected participants of their acceptance into the Support for Clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program. May 28, 2024: FDA issued platform technology guidance to increase drug development efficiency (also see Information for industry below) May 23, 2024: FDA Voices: Treatment Using Medication for Opioid Use Disorder Can Save Lives - Also see Prescribe with Confidence, a new campaign that aims to help primary care providers recognize and treat opioid use disorder.  May 20, 2024: FDA Voices: FDA Promotes Clinical Trial Innovation Recent reports published by FDA: Generic Drug User Fee Amendments (GDUFA) FY 2023 Science and Research Report (FDA Center for Drug Evaluation and Research [CDER]) Annual Report to Congress on Drug Shortages for calendar year 2023 (CDER and the FDA Center for Biologics Evaluation and Research [CBER]) More FDA press announcements

HPAI response updates 

Highly pathogenic avian influenza (H5N1) in dairy cows  

In response to requests from the public, on May 21, 2024, FDA published a list of in vitro diagnostic tests (IVDs) that have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA), for the detection of influenza in certain specimens from humans. Most tests listed for the detection of seasonal influenza may be capable of detecting influenza A/H5N1, which is a subtype of influenza A. However, only tests specifically designed for subtyping will be able to determine if the person has seasonal flu, or influenza A/H5. Learn more and view the list: Influenza Diagnostic Tests

Recent updates from FDA and our federal partners:

• June 4, 2024: Unpasteurized (Raw) Milk and Highly Pathogenic Avian Influenza: Advice for Healthcare Providers (CDC)
• May 31, 2024: Fact Sheet: In Response to H5N1, HHS and USDA Focus on Protecting Farmworkers (HHS)
• May 30, 2024: Updates on H5N1 Beef Safety Studies (USDA)
• May 30, 2024: CDC Confirms Second Human H5 Bird Flu Case in Michigan; Third Case Tied to Dairy Outbreak (CDC) - CDC's risk assessment for the general public who do not have exposure to infected animals remains low.
• May 29, 2024: Study Shows Novel Influenza Virus Infections in Humans in the United States Would Likely be Detected Through Existing Health Care Surveillance (CDC)
• May 24, 2024: High H5N1 Influenza Levels Found in Mice Given Raw Milk from Infected Dairy Cows (NIH/NIAID)
• May 23, 2024: USDA Expands Support for Producers to Stop the Spread of H5N1 in Dairy Cattle (USDA)
• May 22, 2024: Audio Interview: Preparing for a Possible Avian Influenza Outbreak with Dr. Demetre Daskalakis, Director of the CDC’s National Center for Immunization and Respiratory Diseases, and Dr. Hilary Marston, FDA Chief Medical Officer (New England Journal of Medicine, 31 minutes)
• May 22, 2024: Recommendations to Minimize Influenza Transmission at Dairy Cattle Livestock Exhibitions (USDA)

Additional information from FDA and our federal partners:

• Questions and answers regarding milk safety and egg safety during HPAI outbreaks (FDA)
• HPAI Detections in Livestock (USDA)
• Current H5N1 Bird Flu Situation in Dairy Cows (CDC)
• How CDC is monitoring influenza data among people to better understand the current avian influenza A (H5N1) situation (CDC)

Consumer information on milk safety from FDA:

• Keeping Your Milk Safe From the Grass to the Glass - A look at what makes your milk and dairy safe, and the 100-year history behind it
• The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk

FDA reorganization update

FDA's reorganization approved for establishing Human Foods Program, new model for field operations and other modernization efforts

FDA reached a significant milestone with approval of its reorganization involving the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations and other significant modernization efforts. The reorganization implementation is currently targeted for October 1, 2024, notably enhancing the agency’s ability to oversee and protect the human food supply and other products the FDA regulates. 

As noted in a previous announcement, the reorganization will establish an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of cross-agency medical issues, including special populations such as people with rare diseases and children. This includes a new Office of Public Health Preparedness and Response to support medical countermeasure policy, emergency preparedness work and medical product shortage coordination across the agency.

The Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) will merge to form a new office; both offices are currently housed within FDA’s Office of the Chief Scientist (OCS). This new merged office in OCS, proposed as the Office of Regulatory and Emerging Science, will strengthen support of regulatory science and preparedness research efforts.

A full list of the changes can be found in the Federal Register notice. (May 30, 2024)

Emergency Use Authorization (EUA) updates

Recent new EUAs Additional information about these EUAs can be found at: In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2  5/8/2024: Speedy Swab Rapid COVID-19 + Flu A&B Antigen Test (Watmind USA) EUA revocations FDA revoked the following EUA for the reasons noted in the revocation letter (PDF):  5/22/2024: Accula SARS-Cov-2 Test (Mesa Biotech Inc.) EUA quick links Emergency Use Authorization - about EUAs, and links to current EUAs EUAs for Drugs and Non-Vaccine Biological Products (CDER) EUAs for Medical Devices (CDRH) COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER) Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked Historical Information about Device EUAs

Events

• June 12, 2024: Medical Device Sterilization Town Hall: Sterilization Open Q&A (virtual)
• June 13, 2024: Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees (virtual listening session) Also see: Advisory Committees Give FDA Critical Advice and the Public a Voice
• June 13, 2024: OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice (virtual)
• June 17-18, 2024: Partnership for DSCSA Governance (PDG)/FDA Joint Public Meeting: DSCSA Stabilization Period Midway Checkpoint (Washington, DC or virtual) - The Partnership for DSCSA Governance (PDG) and FDA are hosting a joint public meeting on the Drug Supply Chain Security Act(DSCSA) implementation and stabilization efforts. This free meeting serves as a checkpoint midway in the stabilization period, affording industry, FDA and others an opportunity to share stabilization progress that has been made, stabilization activity that remains and areas of remaining concern.
• June 26-27, 2024: Co-sponsored Public Workshop: Using Patient-Generated Health Data in Medical Device Development - hosted by FDA and the Digital Medicine Society (virtual)
• June 27, 2024: Webinar – Final Guidance: Remanufacturing of Medical Devices
• July 30 - August 1, 2024: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - Save the date, and pre-register by June 30, 2024 to attend in-person, or by July 12, 2024 to attend virtually. 

Information for industry and health care providers

Guidance and updates for industry

FDA issues platform technology guidance to increase drug development efficiency On May 28, 2024, FDA issued the Platform Technology Designation Program for Drug Development draft guidance. The platform technology designation program was added to the Federal Food, Drug, and Cosmetic Act by the PREVENT Pandemics Act. This program is intended to result in efficiencies in drug or biological product development, manufacturing, and review processes for drugs and biological products incorporating designated platform technologies. Submit comments by July 29, 2024.

Updated FDA safety communication: Evaluating plastic syringes made in China for device failures

On May 23, 2024, FDA announced that Medline Industries, LP, a firm marketing and distributing plastic syringes made in China within the U.S., initiated a recall to stop using affected products which includes unauthorized plastic syringes made in China. Additionally, FDA announced that Jiangsu Shenli Medical Production Co. Ltd, a China-based manufacturer of plastic syringes, initiated a recall to stop using its unauthorized plastic syringes. On June 3, 2024, FDA announced additional recalls. The FDA recommendations have not changed. FDA will continue efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.

Reminder: Seeking input on clinical research terminology glossary

On May 6, 2024, FDA and NIH published a request for information (RFI) seeking public comments on a proposed glossary of clinical research terminology. This glossary is intended to facilitate communication within the clinical research community by helping establish a common vocabulary to more uniformly characterize clinical research. FDA and NIH identified and developed definitions for 37 terms related to innovative clinical study designs. The public comment period will be open through June 24, 2024. 

Expiration date extension You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. Recent extension: On May 28, 2024, FDA granted an extension (PDF) of the shelf-life of lot #96867 of the FDA-approved Jynneos vaccine. FDA is extending the expiration date of a single lot of Jynneos (lot #96867), from 4 weeks to 8 weeks when kept +2°C to +8°C after thawing. This expiration is consistent with the expiration of lots of Jynneos used under EUA and distributed by the Strategic National Stockpile (SNS). The lots of authorized Jynneos that have been distributed by SNS and have an 8-week expiry after thawing can be found at: SNS Products: Vaccines and Treatment Available for Use in the Mpox Response (HHS). Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information about expiration date extensions of at-home COVID-19 tests.

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What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ.