FDA Publishes Over 30 New and Revised Product-Specific Draft Guidances

The FDA published new product-specific draft guidances for establishing bioequivalence in 20 drugs and combinations. The agency also revised draft guidances for 12 substances.

The new guidances include recommendations for developing generics for aspirin and its combination with the heartburn medication Prilosec (omeprazole) — in addition to therapies for schizophrenia, epilepsy and colorectal cancer, as well as antibiotics and a topical corticosteroid. They also include antivirals and combinations for HIV and hepatitis C.

The agency spells out the recommended clinical studies for each active ingredient, including recommended doses, strengths and enrolled patients. Some also include information on waiver requests for in vivo testing and references to additional FDA guidance.