FDA ends CSR pi­lot, plots new ap­proach for dis­clos­ing study re­ports

The FDA on Thurs­day of­fi­cial­ly end­ed a fledg­ling pi­lot pro­gram that was part of an ef­fort to pro­vide more trans­paren­cy on the drug ap­proval process. The agency said it’s work­ing on a new ap­proach to dis­clos­ing study re­ports.

Last June, the agency was al­ready push­ing away from the clin­i­cal study re­port (CSR) pi­lot be­cause of lack­lus­ter par­tic­i­pa­tion (FDA not­ed that Janssen was the on­ly spon­sor that agreed to par­tic­i­pate) and said it would fo­cus its ef­forts to bet­ter com­mu­ni­cate the ba­sis for drug ap­provals on the de­vel­op­ment of new in­te­grat­ed re­view doc­u­ments.

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