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JD Supra40m
AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) ...
STAT2hOpinion
The FDA is circumventing key roles and procedures for licensure and use of Covid vaccines
The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...
STAT4h
Five burning questions on the FDA’s new Covid-19 vaccine framework
Food and Drug Administration Commissioner Marty Makary promised stakeholders last week that the agency’s new Covid-19 vaccine ...