In new draft guidance on tentatively approved applications . . .

FDA Details Timing, Content Of Changes To TA Generic Drug Applications

By Beth Wang / January 16, 2019 at 7:45 PM
In a new draft guidance released Wednesday (Jan. 16), FDA provides recommendations to generic drug makers on how to prepare and submit changes to their tentatively approved drug applications so they can receive final lawful approval on the earliest date possible based on patent and exclusivity protections. The guidance is part of FDA’s larger efforts to bolster competition by promoting timely access to generic medicines, FDA Commissioner Scott Gottlieb tweeted on Wednesday. The draft guide lays out the types of...


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