No­var­tis, Sanofi and PhRMA push FDA on how to bet­ter han­dle com­plex tri­al de­signs

Sev­er­al in­dus­try stake­hold­ers are ask­ing the FDA to stream­line its process­es for work­ing with spon­sors on com­plex and in­no­v­a­tive de­signs for clin­i­cal tri­als. The com­ments seek more clar­i­ty on how the FDA de­cides whether to ac­cept de­signs, fol­low­ing a work­shop on the top­ic last month.

The FDA first be­gan of­fer­ing meet­ings with spon­sors on com­plex de­signs as part of a pi­lot pro­gram un­der the Pre­scrip­tion Drug User Fee Act VI and is now re­view­ing the pro­gram’s progress. The agency pre­vi­ous­ly asked com­pa­nies for feed­back on how to im­prove the pro­gram as it be­comes per­ma­nent.

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