FDA Chief Counsel Defends COVID-19 EUAs, Praises ‘Moral Strength’ Of Commissioner Hahn
Stacy Cline Amin says authorizing or licensing a COVID-19 vaccine is ‘perhaps the most consequential action the agency will ever take.’ Speaking at FDLI conference, she notes that standards for vaccine EUA will be higher than what has been required for therapeutics.
You may also be interested in...
Amin leaves after two-year stint, but Trump administration chaos continues as HHS names a different replacement chief counsel than FDA did earlier in the day. James Lawrence is tapped to be FDA's top lawyer and will presumably help speed a number of regulatory changes at the agency.
Everyone but Donald Trump seems happy that the guidance is finally here, with release appearing to be driven by FDA's disclosure of advisory committee materials.