Pa­tient ex­pe­ri­ence da­ta in reg­u­la­to­ry de­ci­sions: Ques­tions abound in first FDA re­port

The FDA on Tues­day re­leased its first re­port on the use of pa­tient ex­pe­ri­ence da­ta in ap­proval de­ci­sions, al­though it makes clear there’s a lot of work to do on this front as ap­pli­cants, pa­tients, and care­givers said they do not ful­ly un­der­stand how FDA us­es this da­ta in its ap­proval process.

The re­port, pub­lished thanks to the 21st Cen­tu­ry Cures Act, al­so makes clear the way in which the FDA us­es pa­tient ex­pe­ri­ence da­ta in ap­pli­ca­tion ap­proval de­ci­sions varies wide­ly. And drug­mak­ers said they can­not al­ways get a meet­ing with FDA re­view­ers ear­ly enough to dis­cuss the use of pa­tient da­ta.

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