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Pharmaceuticals / Regulatory Affairs

FDA Releases Product-Specific Guidances to Foster Generic Competition

Sept. 17, 2018
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The FDA issued 54 product-specific draft guidances Thursday that offer recommendations for developing 15 generic versions of drugs it says need competition.

FDA Commissioner Scott Gottlieb said the agency is modernizing some of its previously-issued guidance “to reflect the most efficient path for developing generics” in addition to the detailed guidances on drug development.

One of the most effective ways for the FDA to increase patient access to high quality generics is to offer guidance that promotes the development of cost-saving generics, especially for complex drugs that are difficult to copy, he said.

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