FDA+ roundup: Lessons learned from two qual­i­ty rat­ings pi­lots; Ex­pand­ed FDA col­lab with or­gan-on-a-chip com­pa­ny

The FDA since at least 2019 has been fid­dling with the idea of adding drug/ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) man­u­fac­tur­ing qual­i­ty rat­ings or scores as part of an at­tempt to pro­mote bet­ter man­u­fac­tur­ing prac­tices in­dus­try­wide.

The ini­tial idea led to two pi­lot pro­grams — one with sev­en do­mes­tic sites mak­ing fin­ished prod­ucts and the oth­er look­ing in­to eight for­eign sites mak­ing APIs mar­ket­ed in the US — and Jen­nifer Maguire, the FDA’s di­rec­tor of the Of­fice of Qual­i­ty Sur­veil­lance, and CDER col­leagues are now ex­plain­ing the re­sults in a re­cent pub­li­ca­tion in the AAPS Jour­nal, con­clud­ing that ex­pand­ing such a qual­i­ty pro­gram will be ben­e­fi­cial for mul­ti­ple stake­hold­ers:

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