Commissioner Hahn Self-Quarantines, But US FDA's Operations Will Likely Remain Unaffected
Since most employees already are teleworking, Stephen Hahn’s forced isolation due to potential coronavirus exposure should not cause many disruptions, former FDA officials say.
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At Senate hearing, FDA and NIH officials say government and vaccine developers are outlining production needs with ability to shift manufacturing from their candidates to others to ensure production of the most promising products. FDA Commissioner Hahn says as an essential worker he would break quarantine if needed at a critical White House or other meeting.
After Remdesivir's Emergency Use Authorization, US Gov't Must Now Decide How To Distribute Limited Supply
Gilead's antiviral remdesivir will go to hospitalized severe COVID-19 patients per FDA's EUA. Some cities could receive the medicine with days, but it is not clear how the government will dole out the limited supplies. FDA said it had access to non-public data from a key NIH trial during its EUA review.
New drug approvals dropped, likely because of a new focus on COVID-19 treatments, while generic drug approvals increased.