FDA releases new product-specific guidance for generic drugs

The US Food and Drug Administration (FDA) has issued new draft guidance on 21 generic medicines.

The FDA has, for a number of years, published product-specific guidance documents that give a clear insight on agency expectations on how generic drug products should be developed.

The guidance, for each drug, details the in vitro and in vivo studies required to demonstrate bioequivalence (BE) with the reference listed drug and thereby to support the registration of a generic medicine.  Where an in vivo BE waiver may be applicable, the guidance includes provisions and product criteria for obtaining such a waiver.

Also published are revised documents for 16 generic drugs.

To see the products for which new and revised guidance documents have been released and to access the guidance documents, please click here.