FDA cen­ter di­rec­tors on lessons from the EUA path­way: Flex­i­bil­i­ty serves us well

The flex­i­bil­i­ty of emer­gency use au­tho­riza­tions, and al­low­ing the FDA to ac­cept more un­cer­tain­ty dur­ing the pan­dem­ic so far, has ul­ti­mate­ly aid­ed its re­sponse to Covid-19, cen­ter di­rec­tors said Tues­day at a work­shop at the Na­tion­al Acad­e­mies of Sci­ences, En­gi­neer­ing and Med­i­cine.

Pa­trizia Cavaz­zoni, di­rec­tor of the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search, point­ed to the agili­ty of the EUAs, and the abil­i­ty to quick­ly re­voke any EUAs, as well as the trans­paren­cy around those de­ci­sions as to what led to the evo­lu­tion of the types of ther­a­peu­tics that have been au­tho­rized (see chart be­low).

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