FDA Biologics @FDACBER
Latest information from the Center for Biologics Evaluation and Research. Contact us at 1-800-835-4709 or [email protected]. http://t.co/5Fo6rzyhYQ fda.gov/BiologicsBlood… Silver Spring, MD Joined May 2011-
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Step into the forefront of novel endpoint development for rare disease drug development! CBER invites you to submit a proposal to the Rare Disease Endpoint Advancement (RDEA) Pilot Program, a collaboration with @FDA_Drug_Info. Deadline is 9/30/25! bit.ly/48UBUx4
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FDA Biologics retweeted
Today, we approved a first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adult patients with recurrent respiratory papillomatosis. fda.gov/news-events/pr…
CBER invites you to submit a proposal to the Rare Disease Endpoint Advancement (RDEA) Pilot Program, a collaborative initiative with @FDA_Drug_Info. Join us in advancing development of #RareDiseaseTherapies. Submit your proposal now! bit.ly/48UBUx4
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.
FDA Biologics retweeted
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.
FDA Biologics retweeted
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/…
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/… https://t.co/CUVME7XTAn
FDA Biologics retweeted
LIVE NOW: FDA's Cell and Gene Therapy Roundtable Captions available here: bit.ly/4dQaNaz
FDA Biologics retweeted
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…
FDA Biologics retweeted
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…
FDA Biologics retweeted
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…
U.S. FDA @US_FDA
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ABC News Health @ABCNewsHealth
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