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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 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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