FDA Guidances Aim To Streamline Application Process For Drug Developers

By Beth Wang / September 24, 2018 at 6:08 PM
FDA issued two guidances on Monday (Sept. 24) -- one final and one draft -- aimed at streamlining the review process for generic, brand and biologics drugs and helping developers submit high-quality applications from the get-go to avoid going through multiple review cycles, the agency announced Monday (Sept. 24). FDA Commissioner Scott Gottlieb said the guidances are part of the agency's efforts to lower drug prices and improve access to innovative medicines. The guidances, part of FDA’s Drug Competition Action...


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