FDA says vol­ume man­u­fac­tur­ing dead­line is not a re­quire­ment af­ter drug­mak­ers lash out

Back in Oc­to­ber, the FDA re­leased a con­tro­ver­sial draft guid­ance ex­plain­ing to drug man­u­fac­tur­ers how, be­gin­ning on Feb. 15, 2022, the FDA would start col­lect­ing an­nu­al man­u­fac­tur­ing re­ports.

It would start with 2020 man­u­fac­tur­ing da­ta, in­clud­ing the vol­ume or amount of each drug, and the same for ac­tive phar­ma­ceu­ti­cal in­gre­di­ents.

The re­ports were cre­at­ed as part of the CARES Act, en­act­ed in May 2020, which aid­ed the Covid-19 re­sponse fund­ing and added new pro­vi­sions, like this one, meant to ad­dress pan­dem­ic-ex­ac­er­bat­ed drug short­ages, by im­prov­ing FDA’s vis­i­bil­i­ty in­to drug/API sup­ply chains.

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