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FDA Posts New Batch of Product-Specific Guidances

March 10, 2020

The FDA released its latest update of product-specific guidances on bioequivalence needed to support generics, including 33 new draft and 10 revised guidances. The agency has issued 1,832 of the product-specific guidances to date.

Thirty-eight of the guidances are for ANDAs with no approved products, including 14 complex products.

The agency also updated its list of product-specific guidances for complex generics that it plans to release this year, including 52 new and 54 revised guidances.

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