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Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic dr

U.S. Food & Drug Administration press release --------- The FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved. The new steps we’re announcing today go toward achievement of this third goal. We expect to take additional steps this year to promote competition; to help reduce drug prices and improve access to medicine for Americans. To get more in depth information click on the picture below to read the release.

Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices - Read More from FDA

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