How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drug­mak­ers look­ing to de­sign a new reg­istry or use an ex­ist­ing one to sup­port a reg­u­la­to­ry de­ci­sion on a drug’s ef­fec­tive­ness or safe­ty will need to con­sult with a new draft guid­ance re­leased Mon­day by the FDA.

The agency’s re­liance on reg­istry da­ta for reg­u­la­to­ry de­ci­sions dates back more than two decades, at least, as in 1998 Bay­er won ap­proval for its an­ti­co­ag­u­lant Re­flu­dan (with­drawn from the mar­ket in 2013 for com­mer­cial rea­sons) based in part on a his­tor­i­cal con­trol group pulled from a reg­istry.

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