Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulationsApril 3, 2019Stem cell therapies offer the potential to treat o [...]
Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adultsApril 3, 2019
Wakefern Food Corp. Voluntarily Recalls Wholesome Pantry Organic Nut Butters Because of Possible Health RiskApril 2, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devicesApril 2, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived productsApril 2, 2019
FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioidsApril 2, 2019
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, 2019
NadaMoo! Voluntarily Recalls Select Pints of Strawberry Cheesecake Due to Undeclared AlmondApril 1, 2019
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
Nestle Purina PetCare Company Voluntarily Recalls a Limited Amount of Muse Wet Cat Food Natural Chicken Recipe in Gravy in Three-ounce Cans due to the Potential Presence of Rubber PiecesMarch 29, 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
Thomas Hammer Coffee Roasters Inc. Issues Allergy Alert on Undeclared Egg in Blueberry BreadMarch 29, 2019
Theo Chocolate Issues Allergy Alert on Undeclared Milk in 3oz Sea Salt 70% Dark Chocolate BarsMarch 28, 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
