The US Food and Drug Administration (FDA) has over the years come up with initiatives to protect the interests of both the patented and generic drug manufacturers. The FDA has come up with a new approval pathway which is the Competitive Generic Therapy(CGT)directed solely towards pushing generic players to enter the market and improving affordability of older off patent medicines for the public.This program introduced under section 506h of Federal Food, Drug and Cosmetics Act and 21 United States Code Section 356hwasasrecommended by the FDA Reauthorization Act of 2017

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Previously published in Lexology.

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