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Food and Drug Administration and Compliance Issues
Friday, March 13, 2020
FDA In Brief: FDA Finalizes Guidance for Industry on Applications for Drugs with Inadequate Generic Competition
The following quote is attributed to FDA Commissioner Stephen M. Hahn, M.D.:
“Increased competition empowers patients with more choices for their health care. By providing incentives for the development of generic versions of drugs that currently face little or no competition, we are better able to foster the development of more safe and effective generic drugs, which we expect will result in increased access to necessary treatments and potentially lower the cost of these medications.
“In particular, the competitive generic therapy, CGT, designation has been a significant advancement in helping to bolster generic drug competition in the U.S. Since Congress provided us with this authority, we have received more than 350 CGT requests from drug manufacturers and have approved a number of products with this designation.
“The finalization of guidance on CGTs underscores our commitment to encouraging generic entry for drugs that face inadequate competition – a key part of our Drug Competition Action Plan.”