Trans­paren­cy: FDA to re­lease more in­fo on pre­mar­ket re­views

The FDA on Wednes­day sought com­ments on a new ef­fort to pro­vide more clar­i­ty on the agency’s phar­ma­ceu­ti­cal ap­pli­ca­tion re­view and de­ci­sion-mak­ing process.

FDA high­light­ed two ef­forts for which it’s seek­ing fur­ther com­ment: A fledg­ling pi­lot pro­gram launched in Jan­u­ary 2018 that sought to pro­vide more trans­paren­cy on spon­sors’ clin­i­cal study re­ports (CSRs) but on­ly re­sult­ed in the re­lease of one CSR, and a new in­te­grat­ed re­view tem­plate, cur­rent­ly be­ing im­ple­ment­ed, that can bet­ter con­vey the FDA’s analy­sis and de­ci­sion-mak­ing in drug ap­provals.

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