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Katherine Szarama, PhD, named Acting CBER Director: who’s next?

by rss feed | May 1, 2026 | CBER, FDA, Katherine Szarama, News Feeds

Yesterday was Vinay Prasad’s last day as the Director of CBER, the FDA’s biologics branch and as of today Katherine Szarama is Acting Director. Is there some significance to Szarama being acting director? It’s hard to say. Most signs seem to suggest...

Why the FDA & CBER leadership purge will be so bad for biotech

by rss feed | Apr 22, 2025 | CBER, FDA, News Feeds, Trump biotech

The Trump Administration just quickly gutted the FDA including key leadership. What is going to be the impact of this sudden purge? Former Commissioner Robert Califf recently said it is the end of the FDA as we’ve known it. Those are dramatic words, but they...

FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

by rss feed | Oct 29, 2024 | CBER, FDA Warning Letter, News Feeds, PalinGen

Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on biologics CBER is the part of the FDA that regulates...

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