Wednesday, January 30, 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines

As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many policies aimed at making it more efficient to bring generic competition to the market. We’ve been especially focused on a category of medicines known as complex drugs. These are drugs that, by nature of their formulation, delivery systems or the complexity of their active ingredients, for example, are harder to ...

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