Pa­tient ex­pe­ri­ence da­ta: Sanofi re­searchers call for more con­sis­ten­cy from FDA

Re­searchers at drug­mak­er Sanofi are call­ing on the FDA to make its pub­li­ca­tion of pa­tient ex­pe­ri­ence da­ta (PED) in re­view doc­u­men­ta­tion more con­sis­tent af­ter re­view­ing ap­pli­ca­tions ap­proved in the first full year af­ter a re­quire­ment of the 21st Cen­tu­ry Cures Act com­pelled the agency to do so.

Un­der Sec­tion 3001 of the 21st Cen­tu­ry Cures Act, the FDA is re­quired to “pub­lish a brief state­ment on any pa­tient ex­pe­ri­ence da­ta or re­lat­ed in­for­ma­tion that was part of the ap­pli­ca­tion” for ap­pli­ca­tions sub­mit­ted af­ter 16 June 2017.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER