Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfiz­er, GSK, Janssen, Re­gen­eron, Boehringer In­gel­heim and at least a half dozen oth­er com­pa­nies are call­ing on the FDA to pro­vide sig­nif­i­cant­ly more clar­i­ty in its draft guid­ance from this sum­mer on clin­i­cal out­come as­sess­ments, which are a type of pa­tient ex­pe­ri­ence.

The draft is the third in a se­ries of four pa­tient-fo­cused drug de­vel­op­ment guid­ance doc­u­ments that the FDA had to cre­ate as part of the 21st Cen­tu­ry Cures Act, and they de­scribe how stake­hold­ers (pa­tients, care­givers, re­searchers, med­ical prod­uct de­vel­op­ers and oth­ers) can col­lect and sub­mit pa­tient ex­pe­ri­ence da­ta and oth­er rel­e­vant in­for­ma­tion for med­ical prod­uct de­vel­op­ment and reg­u­la­to­ry de­ci­sion-mak­ing.

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