Am­gen, Re­gen­eron and oth­ers seek more de­tail from FDA on re­al-world da­ta plans

Back in late Sep­tem­ber, the FDA re­leased a long-await­ed guid­ance on how the in­dus­try might use elec­tron­ic health records (EHRs) or med­ical claims da­ta in clin­i­cal stud­ies to sup­port a reg­u­la­to­ry de­ci­sion for ef­fec­tive­ness or safe­ty.

The draft guid­ance of­fered some light from FDA on which strate­gies might help a spon­sor get a new ap­proval across the fin­ish line or help with an sN­DA or sBLA. A to­tal of 57 com­ments were filed on the draft, with some com­pa­nies like Re­gen­eron, Janssen, and Am­gen, as well as in­dus­try groups like PhRMA and the RWE Al­liance, seek­ing ad­di­tion­al clar­i­ty and of­fer­ing sug­ges­tions.

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