USA – FDA Issues 43 Product-Specific Guidances for Generic Drugs

The US Food and Drug Administration (FDA) on Monday released a batch of 43 new and revised draft product-specific guidances to support the development of generic drugs.

The guidances, when finalized, are intended to promote generic competition by clarifying FDA’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, FDA has issued a total of 1,832 product-specific guidances…