FDA issues 69 new and revised draft product-specific guidances

The US Food and Drug Administration (FDA) on Wednesday released 26 new and 43 revised draft product-specific guidances to support the development of generic drugs.

The guidances, when finalized, are intended to promote generic competition by clarifying the agency’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 1,903 product-specific guidances.