On September 17th, the FDA published 53 product-specific draft guidances (PSGs) to facilitate generic drug development. 34 are brand new, and 16 (5 new and 11 revised) are for complex drug products, aligning with next week’s webinar on that topic. Nearly half are for products with no approved Abbreviated New Drug Application (ANDA). These PSGs list the studies and information recommended for ANDA submissions for each product, which are generally focused on bioequivalence and dissolution studies, but may differ where the drug product is not a capsule or tablet (for example, in the hydrogen peroxide PSG).
The agency also updated its list of upcoming PSGs for complex drug product development with their plans for complex drug product PSGs in the upcoming year. The web page for this list will be updated quarterly as the FDA issues additional guidance. As always, public comments on the new guidances are requested and may be submitted through the notice in the Federal Register through November 18th.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2019 Katrina Rogers