Food and Drug Administration Safety and Innovation Act

Oct 02, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter 'gaming' of the generic drug approval process by the use of citizen petitions

Sep 28, 2018

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

Aug 08, 2018

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

Jun 19, 2018

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA's Center for Drug Evaluation and Research, on the agency's response to ongoing drug shortages for critical products

May 31, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities

Feb 15, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA's new drug review programs

Jan 16, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA's ongoing efforts to increase access to complex generic drugs

Jan 03, 2018

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