FDA+ roundup: Flur­ry of guid­ance doc­u­ments, up­dat­ed risk cri­te­ria for Covid-19 mAbs, per­son­nel moves and more

The FDA re­mains with­out a per­ma­nent com­mis­sion­er but as act­ing com­mis­sion­er Janet Wood­cock told the Food and Drug Law In­sti­tute’s an­nu­al con­fer­ence yes­ter­day, noth­ing at the agency is slow­ing down as a re­sult.

With the re­lease of new guid­ance doc­u­ments on mas­ter pro­to­cols and oth­er drug de­vel­op­ment changes, as well as FDA staff moves, up­dates on who should re­ceive Covid-19 mAb treat­ments, prepa­ra­tions for a big pub­lic meet­ing next month on fi­nan­cial trans­paren­cy and ef­fi­cien­cy, the agency has its hands full.

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