FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development

Regulatory NewsRegulatory News | 16 September 2019 |  By 

The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products.

When finalized, the guidance documents will represent the current thinking of FDA on, among other things, the product-specific design of bioequivalence studies to support abbreviated new drug applications.

Among the new documents include draft guidance to help generic drugmakers develop versions of Pharmacyclics and Janssen’s cancer drug Imbruvica (ibrutinib), the smallpox treatment Tpoxx (tecovirimat), Verstem’s cancer drug Copiktra (duvelisib) and Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib).

Revised draft guidance includes recommendations for those looking to develop generic versions of the ulcerative colitis drug mesalamine, the sleep disorder drug armodafinil and the Crohn's disease and ulcerative colitis treatment budesonide, among others.

This is the third time in 2019 that FDA has released new and revised guidance documents, with the previous releases occurring in May and February.

Product-Specific Guidances for Generic Drug Development


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Tags: FDA, generic, guidance

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