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 […]
The Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium will be held 4 May and 18 May 2023. This first session will be held from 8:00am-12:00pm ET on 4 May 2023 and the second session from 8:00 am-12:00pm ET on 18 May 2023. The purpose of this symposium is to convene global health planning […]
The Annual Meeting of the Association of Biomolecular Resource Facilities (ABRF 2023) will be held 7-10 May 2023 in Boston, Massachusetts. Highlighted topics and presentations include: Business Skills for Core Facility Directors, Managers and Administrators Advancing Single Cell in Core Laboratories Implementing Spatial Transcriptomics in Core Facilities Using R/R-Studio for reproducible data analysis and visualization […]
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, […]
The Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium will be held 18 May 2023. This is the second of two sessions. The purpose of this symposium is to convene global health planning stakeholders, including those in government and academia, and across health- and non-health sectors, to strengthen the capacity for evidence-based prioritization of global […]
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 […]
