http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types Today, the U.S. Food and Drug Administration granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. Fri, 29 Sep 2023 18:06:49 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types http://www.fda.gov/news-events/press-announcements/fda-roundup-september-29-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 29 Sep 2023 16:01:42 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-september-29-2023 http://www.fda.gov/news-events/press-announcements/fda-launches-pilot-program-help-further-accelerate-development-rare-disease-therapies The FDA is announcing the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing late-phase product development issues. Fri, 29 Sep 2023 12:31:21 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-launches-pilot-program-help-further-accelerate-development-rare-disease-therapies http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests Today, the U.S. Food and Drug Administration announced a proposed rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests Fri, 29 Sep 2023 09:00:32 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests http://www.fda.gov/news-events/press-announcements/fda-seeks-fines-against-22-retailers-selling-illegal-youth-appealing-e-cigarettes The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand. Thu, 28 Sep 2023 11:48:00 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-seeks-fines-against-22-retailers-selling-illegal-youth-appealing-e-cigarettes http://www.fda.gov/news-events/press-announcements/fda-roundup-september-26-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 26 Sep 2023 15:45:12 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-september-26-2023 http://www.fda.gov/news-events/press-announcements/fda-draft-guidance-could-result-safer-food-options-people-allergies-sesame-other-food-allergens The FDA announced the availability of two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human food rule mandated by the FDA Food Safety Modernization Act. Tue, 26 Sep 2023 10:12:11 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-draft-guidance-could-result-safer-food-options-people-allergies-sesame-other-food-allergens http://www.fda.gov/news-events/press-announcements/fda-roundup-september-22-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 22 Sep 2023 16:12:44 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-september-22-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-september-19-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 19 Sep 2023 15:37:32 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-september-19-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-september-15-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 15 Sep 2023 15:55:38 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-september-15-2023 http://www.fda.gov/news-events/press-announcements/fda-supports-innovation-animal-biotechnology-veterinary-products-food-animals-through-new The FDA is announcing steps it is taking to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase regulatory flexibility, predictability and efficiency. Fri, 15 Sep 2023 11:03:04 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-supports-innovation-animal-biotechnology-veterinary-products-food-animals-through-new http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products FDA has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. Tue, 12 Sep 2023 10:43:27 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products http://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating FDA approved and authorized for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19. Mon, 11 Sep 2023 13:42:45 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating http://www.fda.gov/news-events/press-announcements/fda-roundup-september-8-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 08 Sep 2023 17:47:30 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-september-8-2023 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