Tuesday, May 4, 2021

From Our Perspective: FDA’s Actions Create Transparency and Value for Complex Generic Product Development - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

Generic Drugs in the 21st Century: FDA's Actions Create Transparency and Value for Complex Generic Product Development

Advancing complex generic drug development is an important part of FDA's goal to help make sure patients have access to a broad range of potentially cost-saving medicines.

Complex generic products generally have complex active ingredients, dosage forms, routes of administration, or drug-device combinations. Examples of complex products include inhalers, topical products, and extended release injectables. Generics of complex brand name drugs or reference listed drugs can be more difficult to develop. As such, a complex drug product is less likely to have an available generic.

In this From Our Perspective, FDA's Robert Lionberger, PhD, Director of the Office of Research and Standards in CDER's Office of Generic Drugs, discusses the agency's actions to create transparency and value for complex generic product development.

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