In­dus­try calls for changes in two REMS guid­ances

In­dus­try groups rep­re­sent­ing the phar­ma­ceu­ti­cal, biotech­nol­o­gy and gener­ic drug in­dus­tries are call­ing for changes to two re­cent FDA draft guid­ances on REMS.

The draft guid­ances, re­leased for com­ment in Jan­u­ary, de­tail a frame­work for com­pa­nies to de­vel­op an as­sess­ment plan for their REMS pro­grams and pro­vide rec­om­men­da­tions for sur­vey­ing pa­tient and health care provider knowl­edge of REMS in­for­ma­tion.

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