GAO to FDA: Do more to en­cour­age drug man­u­fac­tur­ing in­no­va­tion

The Gov­ern­ment Ac­count­abil­i­ty Of­fice on Fri­day re­leased a re­port call­ing on the FDA to bet­ter en­cour­age the adop­tion of ad­vanced drug man­u­fac­tur­ing prac­tices, par­tic­u­lar­ly as in­ter­views with 15 stake­hold­ers from in­dus­try said de­lays in adopt­ing ad­vanced tech are re­lat­ed to reg­u­la­to­ry un­cer­tain­ties.

In ad­di­tion to not en­cour­ag­ing more ad­vanced man­u­fac­tur­ing prac­tices, like con­tin­u­ous man­u­fac­tur­ing, GAO found that the FDA “lacks in­for­ma­tion on the ex­tent to which its in­dus­try en­gage­ment and pol­i­cy and guid­ance ef­forts en­cour­age adop­tion of ad­vanced man­u­fac­tur­ing.” What’s more, the FDA has not even de­fined or doc­u­ment­ed its goals in this area, GAO found.

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