FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirementsMarch 19, 2019Today, the U.S. [...]
Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA’s food safety program for 2020 and beyondMarch 19, 2019
FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditionsMarch 19, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questionsMarch 15, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on advancing new tools and science for implementing agricultural water requirements for produce safetyMarch 15, 2019
Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product developmentMarch 14, 2019
FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitationMarch 14, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigarsMarch 13, 2019
Federal judge enters consent decree against Texas compounder, Guardian Pharmacy ServicesMarch 12, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance the safety of food, compounded drugs, U.S. blood supplyMarch 11, 2019
FDA takes steps to help reduce risks associated with surgical staplers and implantable staplesMarch 8, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmonMarch 8, 2019
USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and PoultryMarch 7, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these productsMarch 7, 2019
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinicMarch 5, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safetyMarch 5, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention PlanMarch 4, 2019
FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recallMarch 1, 2019
