Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
Category Archives: Drug Safety Information Podcasts
FDA, USDA announce formal agreement to bolster coordination and collaboration
FDA Commissioner Dr. Scott Gottlieb and USDA Secretary Perdue launched an effort today to increase collaboration, efficiency and effectiveness, and provide clarity to food producers.
FDA approves new treatment for certain digestive tract cancers
FDA approves first radioactive drug for a certain type of digestive tract cancer called GEP-NETs
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study
FDA strengthens commitments to humane and judicious animal research and the termination of a nicotine study
FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims
FDA and FTC issued joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal
Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls
FDA discusses new policy steps for strengthening public warning and notification of recalls
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
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
GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA — that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.
FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids
FDA updates on some ongoing shortages related to IV fluids
FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel
The U.S. Food and Drug Administration and the Department of Defense launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.