FDA clos­es out se­ries of pa­tient-fo­cused drug de­vel­op­ment guid­ance

The FDA on Wednes­day re­leased its fourth (of four) pa­tient-fo­cused drug de­vel­op­ment guid­ance doc­u­ments, with this lat­est draft fea­tur­ing long-await­ed ad­vice on how to col­lect and sub­mit da­ta on the in­di­vid­ual ex­pe­ri­ences of pa­tients to in­form reg­u­la­to­ry de­ci­sions.

So-called clin­i­cal out­come as­sess­ment (COA)-based end­points fea­ture promi­nent­ly in the draft, with the FDA say­ing COAs are “in­tend­ed to re­flect, di­rect­ly or in­di­rect­ly, how pa­tients feel, func­tion, or sur­vive.” But there are lots of dos and don’ts when it comes to COAs, and spon­sors may fre­quent­ly en­counter chal­lenges, many of which are out­lined in the 45-page draft.

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