http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-roundup-july-28-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 28 Jul 2023 16:31:14 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-july-28-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product The U.S. Food and Drug Administration approved the second naloxone nasal spray product available without a prescription. Fri, 28 Jul 2023 12:49:26 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product http://www.fda.gov/news-events/press-announcements/fda-takes-steps-facilitate-innovation-devices-intended-treat-opioid-use-disorder The draft guidance, to help sponsors design clinical studies to evaluate these devices, furthers the FDA’s Overdose Prevention Framework goal of advancing evidence-based treatment for those with substance use disorders. Thu, 27 Jul 2023 10:12:23 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-takes-steps-facilitate-innovation-devices-intended-treat-opioid-use-disorder http://www.fda.gov/news-events/press-announcements/fda-roundup-july-25-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 25 Jul 2023 15:14:57 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-july-25-2023 http://www.fda.gov/news-events/press-announcements/fda-provides-update-regarding-storm-damage-pfizer-facility-north-carolina The FDA is providing an update regarding storm damage at Pfizer facility in North Carolina. Fri, 21 Jul 2023 18:37:01 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-provides-update-regarding-storm-damage-pfizer-facility-north-carolina http://www.fda.gov/news-events/press-announcements/fda-roundup-july-21-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 21 Jul 2023 16:01:15 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-july-21-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-july-18-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 18 Jul 2023 15:16:48 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-july-18-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers The FDA approved the first drug for the prevention of RSV lower respiratory tract disease in babies and toddlers. Mon, 17 Jul 2023 12:39:50 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers http://www.fda.gov/news-events/press-announcements/fda-roundup-july-14-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 14 Jul 2023 15:39:01 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-july-14-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive The FDA approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. Thu, 13 Jul 2023 08:31:41 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive http://www.fda.gov/news-events/press-announcements/fda-roundup-july-11-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 11 Jul 2023 15:16:25 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-july-11-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-july-7-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 07 Jul 2023 16:30:18 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-july-7-2023 http://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval The FDA converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Thu, 06 Jul 2023 16:42:13 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval http://www.fda.gov/news-events/press-announcements/fda-ftc-warn-six-companies-illegally-selling-copycat-food-products-containing-delta-8-thc FDA, FTC issued warning letters to six companies for illegally selling copycat food products containing delta-8 THC in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Wed, 05 Jul 2023 10:38:30 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-ftc-warn-six-companies-illegally-selling-copycat-food-products-containing-delta-8-thc http://www.fda.gov/news-events/press-announcements/fda-roundup-june-30-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 30 Jun 2023 14:29:50 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-june-30-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-adults-severe-hemophilia FDA approves Roctavian, the first adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A. Thu, 29 Jun 2023 18:01:37 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-adults-severe-hemophilia http://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes The FDA approved Lantidra, the first cellular therapy for the treatment of adults with type 1 diabetes who are unable to approach average blood glucose levels because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Wed, 28 Jun 2023 17:58:25 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes http://www.fda.gov/news-events/press-announcements/fda-roundup-june-27-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 27 Jun 2023 15:11:38 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-june-27-2023 http://www.fda.gov/news-events/press-announcements/fda-provides-update-proposal-unified-human-foods-program-including-new-model-office-regulatory The FDA is providing an update on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). These additions to the FDA Commissioner’s proposal announced earlier this year will further enhance coordination, prevention and respon Tue, 27 Jun 2023 14:03:35 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-provides-update-proposal-unified-human-foods-program-including-new-model-office-regulatory http://www.fda.gov/news-events/press-announcements/fda-roundup-june-23-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 23 Jun 2023 15:02:50 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-june-23-2023