FDA+ guid­ance roundup: Ben­e­fit-risk as­sess­ments, RWE to sup­port reg­u­la­to­ry de­ci­sion-mak­ing, and more

The FDA on Wednes­day un­loaded six new draft and fi­nal guid­ance doc­u­ments across a range of top­ics, in­clud­ing two new drafts, both thanks to the 21st Cen­tu­ry Cures Act, an over-arch­ing one on FDA’s ben­e­fit-risk as­sess­ments, and one on the da­ta that can be ex­tract­ed from med­ical claims and elec­tron­ic health records and used in reg­u­la­to­ry de­ci­sions.

For the 20-page draft guid­ance on ben­e­fit-risk as­sess­ments, the agency spells out in de­tail how it goes about con­duct­ing its ben­e­fit-risk as­sess­ments, which it notes be­come “more chal­leng­ing” when there are se­ri­ous safe­ty risks that are life-threat­en­ing or as­so­ci­at­ed with sig­nif­i­cant mor­bid­i­ty.

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