Man­u­fac­tur­ers sound off on FDA drug re­port­ing guid­ance, point­ing to chal­lenges and rec­om­men­da­tions

In 2020, as a re­sult of the CARES Act, drug man­u­fac­tur­ers are now re­quired to re­port new da­ta an­nu­al­ly to the FDA, in­clud­ing the amount of each list­ed drug that was man­u­fac­tured, pre­pared or processed for dis­tri­b­u­tion.

The guid­ance, which was un­veiled last year, de­tailed specifics about re­port­ing with the changes to the Na­tion­al Drug Code (NDC), as well as oth­er de­tails sur­round­ing spe­cif­ic prod­ucts and how they should be re­port­ed. While man­u­fac­tur­ers of APIs, drugs and con­sul­tants did get their re­ports to the FDA, there was still a lev­el of con­fu­sion and a need to clar­i­fy some de­tails.

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