FDA

The U.S. Food and Drug Administration (FDA) is hosting a virtual public meeting  25 April 2023 on Patient-Focused Drug Development for Long COVID. This meeting will provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID, including how Long COVID affects their daily life, symptoms that matter

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 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

2023 Scientific Computing Days Sharing and Collaboration in the Data Multiverse:Scientific Computing for Public Health Solutions The 11th annual Scientific Computing Days symposium is a conference promoting the latest advances in scientific computing technologies. The event’s goal is to help FDA improve the application of technology and scientific computing in support of the FDA’s public