Can post-market evidence generation be streamlined? FDA-commissioned report proposes solutions

As the FDA seeks to bring a greater fo­cus to im­prov­ing post-mar­ket ev­i­dence gen­er­a­tion, a new re­port from the Rea­gan-Udall Foun­da­tion of­fers some po­ten­tial so­lu­tions to the sys­tem it says is too cost­ly and com­pli­cat­ed.

The Rea­gan-Udall Foun­da­tion of­fered more than two dozen rec­om­men­da­tions for im­prov­ing post-mar­ket ev­i­dence gen­er­a­tion sys­tems, in­clud­ing sim­pli­fy­ing pro­to­col ob­jec­tives and in­creas­ing pa­tient in­volve­ment.

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