Con­gress mulls soft­er ac­cel­er­at­ed ap­proval re­forms as part of user fee reau­tho­riza­tions

New­ly pro­posed, must-pass bi­par­ti­san leg­is­la­tion that pays the FDA over the next five years for its re­views of new med­ical prod­ucts may al­so in­clude new pro­vi­sions al­low­ing the FDA to re­quire con­fir­ma­to­ry tri­als to be un­der­way pri­or to grant­i­ng ac­cel­er­at­ed ap­provals.

The shift would spell bad news for com­pa­nies that win ac­cel­er­at­ed ap­provals but drag their feet in con­duct­ing the re­quired con­fir­ma­to­ry tri­als.

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