Complex ANDAs To Be Allowed Pre-Submission Product Meetings
FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.
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US FDA offers best practices and tips to ensure successful meetings, although few have been conducted so far.
Commissioner Gottlieb previews actions agency intends to take in 2019 to smooth the regulatory and scientific pathway for generics of complex drugs, including draft guidance with recommendations on establishing active ingredient sameness.
Given the pressing need for more affordable versions of complex drug products like peptides, liposomes, transdermals and metered dose inhalers, FDA is encouraging generic drug companies to submit more applications for generic alternatives. FDA encourages industry to leverage agency-sponsored research for more advice on how to submit applications that will get approved.