FDA and DoD formalize collaboration to advance medical products in support of American military personnel. New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military.
Category Archives: Drug Recalls & Safety Notices
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids
FDA announces approval of Dsuvia and new steps the agency may be taking to evaluate opioids.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin
Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.
Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks
Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks
Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure
Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program report release on radiofrequency energy exposure
Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications
FDA warns consumers about concerns with pharmacogenetic tests whose claims have not been reviewed by FDA
FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use
Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use.
FDA takes action to stop the use of lead acetate in hair dyes
FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.