FDA Issues Nearly 50 Product-Specific Guidances for Generics Producers

The FDA has issued nearly 50 draft product-specific guidances (PSG) meant to help accelerate generic drug development by industry sponsors.

“The guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications” (ANDAs), said the agency in a Federal Register notice published Tuesday.

Of the new and updated draft PSGs released, 13 guidances pertain to complex generic products, covering products with a complex active ingredient, formulation, route of delivery or dosage form. And more PSGs on complex generics are expected soon. On its website, the agency lists a further 69 complex generics set to receive draft guidances.

There are also 28 draft guidances for reference products currently lacking an approved ANDA, and the drafts cover a wide range of reference drugs.