Study: Just half of post­mar­ket­ing com­mit­ment tri­als are pub­lished

A new study pub­lished Mon­day in BMC Med­i­cine finds that on­ly about half of the clin­i­cal tri­als re­quest­ed by the FDA as part of post­mar­ket­ing com­mit­ments for new­ly ap­proved drugs and bi­o­log­ics are pub­lished in peer-re­viewed jour­nals.

The study al­so found that in­for­ma­tion for near­ly half of the post­mar­ket­ing com­mit­ment stud­ies sub­ject to re­port­ing re­quire­ments un­der sec­tion 506B of Fed­er­al Food, Drug, and Cos­met­ic Act (FD­CA) was not up to date.

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