UPDATED: Who Can Sign US FDA EUAs? Expect Center Directors And Their Deputies Going Forward
Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.
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Comfort with the initial approval based on inferred effectiveness may have made the current EUA process more palatable to US FDA officials but means there is a bigger gap in what’s known about the vaccine’s effectiveness overall.
The FDA commissioner says that improving health disparities would fix the lack of diversity in clinical trials.
The agency also includes a myocarditis warning in the fact sheet for the first protein-based COVID-19 vaccine to reach the US market.