Friday, June 2, 2023
News on Pathogens and Preparedness

FDA BAA Industry Day 2022

Virtual Event Virtual Event

The U.S. Food and Drug Administration FDA will host an Industry Day on 6 December 2022 to discuss a Broad Agency Announcement (BAA) for state of the art advancements in technology, materials, processes, methods, devices, and techniques in pharmaceutical regulatory science. FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and […]

APEC Medical Product Supply Chain Resilience Dialogue

USP Rockville 12601 Twinbrook Parkway, Rockville, MD, United States
Virtual Event Hybrid Event

FDA and United States Pharmacopeia (USP) are cosponsoring the Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue. This program aims to accelerate APEC and global efforts to strengthen the resilience of global medical product supply chains. This meeting will bring international medical product regulators, multilateral organization representatives, and industry and academic professionals together, to […]

FDA Public Meeting on Patient-Focused Drug Development for Long COVID

Virtual Event Virtual Event

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 […]

Test Development and Validation During the COVID-19 Public Health Emergency

Virtual Event Virtual Event

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 […]

Recombinant Protein-Based COVID-19 Vaccines Workshop

Virtual Event Virtual Event

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 […]

Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products

Virtual Event Virtual Event

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 […]

Collaborating on Culture in the New Era of Smarter Food Safety

Virtual Event Virtual Event

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, […]

VRBPAC Meeting on Pfizer’s ABRYSVO Respiratory Syncytial Virus Vaccine

Virtual Event Virtual Event

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), […]

Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)

Virtual Event Virtual Event

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 […]