Updated: 28h| Published: Saturday
Tracy Beth Høeg was named acting director of the FDA’s CDER, a move senior officials say followed the resignation of Richard Pazdur and clashes with Marty Makary that also preceded the exit of Peter Marks.Senior regulators and industry insiders reported internal complaints, layoffs and alarm among staff who said Høeg lacks experience overseeing drug reviews, with one official calling the decision “like dropping an atom bomb” and others saying she “doesn’t understand laws and regulations.”Industry groups warned the shake-up could politicize FDA decision-making, damage the agency’s reputation as a regulatory standard and prompt some companies to move drug development overseas to seek more stable oversight.
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TracyBethHøeg

Tracy Beth Høeg was named acting director of the FDA’s CDER, a move senior officials say followed the resignation of Richard Pazdur and clashes with Marty Makary that also preceded the exit of Peter Marks. Senior...

Sat/28h
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Twelve former leaders of the FDA have criticized Dr. Vinay Prasad's proposed vaccine policy changes, citing unproven claims in an internal memo about COVID-19 vaccine risks to children. The former commissioners...

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FDA

The FDA has upgraded a recall of more than 1.5 million bags of shredded cheese across 31 states and Puerto Rico to Class II, citing potential metal fragment contamination that could cause temporary or medically...

Wed
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