image credit: Pxfuel

FDA releases coronavirus vaccine guidelines that White House resisted

October 6, 2020

The weeklsong tug-of-war between the FDA and the White House over the agency’s guidelines — normally a routine part of regulatory standard-setting — came to a head in less than 24 hours.

After both The New York Times and Politico reported Monday that White House officials had rejected the guidelines, the agency on Tuesday morning published a briefing document for an Oct. 22 meeting of its vaccine advisory committee. Contained within the document was an appendix spelling out efficacy and safety standards the FDA had already communicated to coronavirus vaccine developers regarding emergency authorization of an experimental shot.

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