FDA Adds/Revises Product-Specific Guidances

November 18, 2022

The FDA has issued 29 new product-specific draft guidances and 22 revised draft guidances for complex and non-complex generic drug products.

The guidances provide product-specific recommendations for the design of bioequivalence studies to support abbreviated new drug applications (ANDAs).

The new draft guidances include budesonide, deferiprone, eteplirsen, fidaxomicin and hydrocortisone. Azelaic acid, ivacaftor and lidocaine are among the revised drafts.

The agency has invited comments on the documents until Jan. 17. View the updated guidance list here: bit.ly/3OgUyGX.

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