http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-roundup-september-1-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 01 Sep 2023 14:01:54 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-september-1-2023 http://www.fda.gov/news-events/press-announcements/la-fda-emite-cartas-de-advertencia-tres-fabricantes-de-formula-infantil La FDA está emitiendo cartas de advertencia a tres fabricantes de fórmula infantil como parte del compromiso continuo de la agencia de mejorar la supervisión normativa para ayudar a garantizar que la industria esté produciendo fórmula infantil en las condiciones más inocuas posibles. Fri, 01 Sep 2023 10:25:02 EDT FDA http://www.fda.gov/news-events/press-announcements/la-fda-emite-cartas-de-advertencia-tres-fabricantes-de-formula-infantil http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-three-infant-formula-manufacturers The FDA is issuing warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible. Wed, 30 Aug 2023 16:06:00 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-three-infant-formula-manufacturers http://www.fda.gov/news-events/press-announcements/fda-roundup-august-29-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 29 Aug 2023 15:06:23 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-29-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-august-25-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 25 Aug 2023 15:53:38 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-25-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-multiple-sclerosis FDA has approved the first biosimilar to Tysabri (natalizumab) injection for the treatment of relapsing forms of multiple sclerosis. Thu, 24 Aug 2023 17:07:28 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-multiple-sclerosis http://www.fda.gov/news-events/press-announcements/fda-names-first-deputy-commissioner-proposed-unified-human-foods-program The FDA has selected James “Jim” Jones to serve as the first Deputy Commissioner for Human Foods. Jones will lead the charge in setting and advancing priorities for a proposed unified Human Foods Program. Jones is scheduled to begin at the FDA on Sept. 24. Wed, 23 Aug 2023 12:16:42 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-names-first-deputy-commissioner-proposed-unified-human-foods-program http://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants FDA approves Abrysvo for immunization at 32 through 36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. Mon, 21 Aug 2023 17:31:19 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants http://www.fda.gov/news-events/press-announcements/fda-roundup-august-18-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 18 Aug 2023 16:07:06 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-18-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-august-15-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 15 Aug 2023 15:51:56 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-15-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-august-11-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 11 Aug 2023 15:43:21 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-11-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-august-8-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 08 Aug 2023 16:29:27 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-8-2023 http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-registration-and-listing-cosmetic-product-facilities-and-products FDA issued a draft guidance which, once finalized, will assist individuals submitting cosmetic product facility registrations and product listings, including ingredients, to the FDA. Mon, 07 Aug 2023 10:07:46 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-registration-and-listing-cosmetic-product-facilities-and-products http://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression The FDA approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities. Fri, 04 Aug 2023 18:49:42 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression http://www.fda.gov/news-events/press-announcements/fda-roundup-august-4-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 04 Aug 2023 17:06:55 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-4-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-august-1-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 01 Aug 2023 17:18:02 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-1-2023 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