Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
Category Archives: Drug Recalls & Safety Notices
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales
The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.
FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation
FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.
FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice
FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.
Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety
FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship
FDA’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship
Michigan-based food manufacturer agrees to stop operations after repeated food safety violations
Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation
Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development
FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice
FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity