A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions
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Plasma Authorization Raises Fears Of Politically-Influenced COVID-19 Vaccine Decisions, Compromised FDA
US FDA Commissioner Hahn’s credibility is in question following an emergency use authorization for convalescent plasma, leading some former officials to push for new agency leadership. Hahn’s actions, combined with President Trump’s attack on FDA staff as being ‘deep state’ actors, may compromise the public trust in the agency’s work during COVID-19 and beyond, former FDA officials say.
The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.