Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand accessApril 2, 2019Access to affordable insulin can be a matter of li [...]
FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standardsApril 1, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettesApril 1, 2019
Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking ForwardMarch 29, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed ruleMarch 28, 2019
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Subcommittee on Appropriations on FDA’s Fiscal Year 2020 budgetMarch 28, 2019
FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadismMarch 27, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl productsMarch 27, 2019
FDA advances landmark policy changes to modernize mammography services and improve their qualityMarch 27, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facilityMarch 26, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., on efforts to promote and foster blood pathogen reduction technologiesMarch 26, 2019
FDA approves new device for treating moderate to severe chronic heart failure in patientsMarch 21, 2019
FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirementsMarch 19, 2019
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
