FDA Issues Generic Drug Development Guidance to Support Approval

The FDA issued 48 product-specific guidance documents on Tuesday that outline the agency’s recommendations for developing generic drugs that treat asthma, allergic reactions, and chronic obstructive pulmonary disease.

The draft product-specific guidances, or PSGs, target medicines that are expected to be therapeutically equivalent to certain drugs, according to the Food and Drug Administration. The agency issued 34 new and 14 revised documents that provide recommendations for developing generics and generating evidence to support abbreviated new drug application approvals.

“These PSGs will streamline generic drug development efforts for a wide-range of products such as providing alternate approaches to more burdensome ...