FDA will al­low ob­ser­va­tion­al stud­ies as part of a push for re­al world ev­i­dence, new frame­work says

The FDA on Thurs­day un­veiled a new frame­work dis­cussing how the agency will use re­al-world ev­i­dence (RWE) and re­al-world da­ta (RWD) to help com­pa­nies win new in­di­ca­tions for ap­proved drugs and bi­o­log­ics, ex­pand la­bels or sat­is­fy post-ap­proval study re­quire­ments.

Specif­i­cal­ly, the agency says its pro­gram will eval­u­ate the use of RWE to sup­port changes to la­bel­ing about drug prod­uct ef­fec­tive­ness, in­clud­ing adding or mod­i­fy­ing an in­di­ca­tion, such as a change in dose, dose reg­i­men or route of ad­min­is­tra­tion; new pop­u­la­tions; or the ad­di­tion of com­par­a­tive ef­fec­tive­ness or safe­ty in­for­ma­tion.

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