The U.S. Food and Drug Administration (FDA) will host a virtual town hall on 26 April 2023 for test developers to discuss the final guidances for the: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Transition Plan for Medical Devices Issued Emergency Use
The Biomedical Advanced Research and Development Authority (BARDA) and FDA will host a virtual workshop titled Recombinant Protein-Based COVID-19 Vaccines April 27, 2023, from 9:00 am EDT to 1:00 pm EDT. The goals of the workshop are to provide a forum for product sponsors to discuss progress and technical challenges in the manufacturing when changing
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public listening meeting on 27 April 2023 to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products. The rapid
Live from the Food Safety Summit: Measure What You Treasure May 11, 2023, from 3:45 pm 5:00 pm ET The upcoming webinar will focus on the importance of assessing food safety culture in an organization. Guest speakers include: Donald A. Prater, DVM, Acting Director, Office of Food Policy and Response, FDA Conrad Choiniere, PhD, Director,
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Announcement On 18 May 2023, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), manufactured by Pfizer Inc., with a requested indication, in Biologics License Application (BLA) 125768 (STN 125768/0),
FDA CDER Office of Pharmaceutical Quality is offering a five-hour webinar to discuss reporting requirements and expectations for Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR). The statutory reporting requirements are found in 21 CFR 314.81 (for FAR) and 21 CFR 600.14 (for BPDR). FDA will share how it assesses these reports and
A BARDA-Sponsored Phase 2 ARDS Platform Clinical Trial BARDA will host 'Just Breathe – An ARDS Therapeutics Pitch Event' on July 24-28, 2023 to support development of threat-agnostic and host-directed therapeutic candidates to address acute respiratory distress syndrome (ARDS). The event will be held in a virtual format. The Biomedical Advanced Research and Development Authority
A closed meeting of the National Institute of Allergy and Infectious Diseases (NIAID) Special Emphasis Panel will be held August 24-25, 2023 to review and evaluate contract proposals for the NIAID 2023 DMID Omnibus BAA (HHS–NIH–NIAID–BAA2023–1), Research Area 004—Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases (N01). The meeting
The National Biodefense Science Board (NBSB) will convene for a virtual meeting on 28 August 2023. The NBSB provides expert advice and guidance to the U.S. Department of Health and Human Services and the Assistant Secretary of Preparedness and Response regarding current and future chemical, biological, radiological, and nuclear threats, as well as other matters
