FDA dis­cuss­es RWD, RWE with in­dus­try, acad­e­mia

In­dus­try, acad­e­mia and FDA of­fi­cials gath­ered Fri­day in Bethes­da, MD to dis­cuss the use of re­al-world da­ta (RWD) and re­al-world ev­i­dence (RWE) in the pre­mar­ket and post­mar­ket set­tings.

Jacque­line Cor­ri­g­an-Cu­ray, di­rec­tor of CDER’s Of­fice of Med­ical Pol­i­cy, kicked off the joint FDA-Amer­i­can As­so­ci­a­tion for Can­cer Re­search meet­ing to dis­cuss the FDA’s frame­work for us­ing RWE, which was un­veiled in De­cem­ber 2018. The frame­work is meant to guide the FDA on eval­u­at­ing the po­ten­tial use of RWE to sup­port changes to la­bel­ing, in­clud­ing adding or mod­i­fy­ing an in­di­ca­tion or adding com­par­a­tive ef­fec­tive­ness or safe­ty in­for­ma­tion.

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