FDA Adds/Revises Product-Specific Guidances
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.
This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective generic drug products, including the projected date of PSG publication, as a commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III). Upcoming PSGs for both complex and non-complex products that are planned to be published in the next 12 months are listed (these may be subject to change).
How often does FDA publish new and revised PSGs?
To support generic drug development and generic drug approval, FDA issues new and revised PSGs on a quarterly and as needed basis. These PSGs, including PSGs for both complex and non-complex generic drug products, when finalized, describe the agency's current thinking and expectations on how to develop generic drug products to specific reference listed drugs and are intended to assist the generic pharmaceutical industry with identifying the most appropriate methodology and evidence needed to support a specific generic drug’s approval. The published PSGs are announced in the Federal Register and made available to the public on FDA’s website.
November 18, 2022
