FDA Biologics

Listen in as CBER Director Dr. Vinay Prasad dives deeper into his recent decision memo related to COVID-19 vaccine approvals. youtu.be/jtudwT6zZwc

FDA provides recommendations to blood establishments that collect blood and blood components, including Source Plasma, for testing blood & blood components for #HepatitisB surface antigen to reduce the risk of transfusion-transmitted Hepatitis B virus. fda.gov/regulatory-inf…

FDA CBER Director Dr. Vinay Prasad shares key take home points explaining the rationale behind recent mRNA COVID-19 vaccine safety label updates. Watch the full discussion here. youtu.be/68QzzWGc4mI

FDA updated COVID-19 vaccine safety labeling based on two key data points. Watch CBER Director Dr. Vinay Prasad discuss these findings. Full video available on the FDA’s YouTube channel. youtu.be/68QzzWGc4mI

The FDA will not negotiate on safety. We will pursue safety signals with the best available scientific methods and ensure that our marketing authorizations are made only to populations where we have substantial confidence the benefits outweigh the risks.

Today, FDA provided important updates on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men.

When we can minimize the burden on the healthcare system, while at the same time ensuring that benefits outweigh risks, we will! The FDA has taken a big step in removing barriers impeding the delivery of cures by removing the REMS requirement for BCMA- and CD19-directed…

Trials vs. real world evidence? The answer to that is both. We will always have a place for controlled clinical studies, but we will also leverage the incredible promise of real world data. Here's more from yesterday's FDA Cell and Gene Therapy Roundtable. x.com/US_FDA/status/…

LIVE NOW: FDA's Cell and Gene Therapy Roundtable Captions available here: bit.ly/4dQaNaz

FDA CBER Director Vinayak Prasad and @DrMakaryFDA discuss an evidence-based approach to COVID-19 vaccination.

Join us for FDA's Center for Biologics Evaluation and Research town hall livestreaming on FDA YouTube, X @US_FDA and Facebook channels tomorrow at 1 pm ET. FDA leaders will discuss an evidence-based approach to COVID vaccination. youtube.com/live/jbRGlEsbK…

More conversation about the nuances of science and policy with FDA Commissioner Makary, Dr. Vinayak “Vinay” Kashyap Prasad, FDA Center for Biologics Evaluation and Research Director and Sanjula Jain-Nagpal, Associate Director of Policy & Research Strategy, Office of the…

We have scheduled a meeting of our Vaccines and Related Biological Products Advisory Committee on May 22 at 8:30 am ET to discuss & make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States. fda.gov/advisory-commi…

I’m proud to welcome Dr. Vinay Prasad, MD, MPH, as the new head of FDA’s Center for Biologics Evaluation & Research. With 500+ peer-reviewed publications and two books, Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant…

Find out what's new in #biologics today. fda.gov/vaccines-blood…

Find out what's new in #biologics today. fda.gov/vaccines-blood…

Today, the FDA posted information on the flu vaccine composition for the 2025-2026 U.S. flu season following a meeting with its federal partners. fda.gov/vaccines-blood…

As we reflect on the close of CY2024, CBER would like to share the accomplishments and advancements we’ve made in public health, in this country and globally. fda.gov/vaccines-blood…

Find out what's new in #biologics today. fda.gov/vaccines-blood…

Need to Register onsite for WCBP 2025? There will be limited availability. Don't miss this opportunity to collaborate, work together and discuss the power of regulatory questions. casss.org/wcbp/registrat… #casss #WCBP2025 #wcbp #biopharmaceuticals #biotechnology #cmc