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.
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US FDA Legal Office’s Pandemic Response: ‘Essentially Nonstop With Some Ebb And Flow’
Former chief counsel Stacy Cline Amin's decision to expand the office's emergency response team, coupled with longstanding professional relationships, have helped the agency’s legal division navigate the public health crisis, acting chief counsel Mark Raza tells FDLI annual meeting.
FDA Chief Counsel Stacy Cline Amin Guided Agency Through COVID-19 EUAs And Guidances
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.
Transparency, And A Mirror: US FDA Advice On COVID-19 Vaccine EUAs Finally Published – Twice
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.