http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-roundup-may-14-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 14 May 2024 13:51:48 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-14-2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-may-10-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 10 May 2024 16:00:03 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-10-2024 http://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-clarify-remanufacturing-devices-need-maintenance-or-repair FDA issued final guidance to provide clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The guidance seeks to ensure consistency while promoting understanding of federal law and regulations implicated by remanufacturing activities. Thu, 09 May 2024 09:59:28 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-clarify-remanufacturing-devices-need-maintenance-or-repair http://www.fda.gov/news-events/press-announcements/epa-fda-and-usda-issue-joint-regulatory-plan-biotechnology The U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, and the U.S. Department of Agriculture have developed a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. Wed, 08 May 2024 14:36:09 EDT FDA http://www.fda.gov/news-events/press-announcements/epa-fda-and-usda-issue-joint-regulatory-plan-biotechnology http://www.fda.gov/news-events/press-announcements/fda-roundup-may-7-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 07 May 2024 16:09:39 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-7-2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-may-3-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 03 May 2024 15:28:25 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-3-2024 http://www.fda.gov/news-events/press-announcements/fda-clarifies-approach-genomic-alterations-animals Today, the FDA took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals. Wed, 01 May 2024 09:20:49 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-clarifies-approach-genomic-alterations-animals http://www.fda.gov/news-events/press-announcements/fda-roundup-april-30-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 30 Apr 2024 15:19:40 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-30-2024 http://www.fda.gov/news-events/press-announcements/fda-hold-listening-session-part-broader-work-optimize-use-and-processes-advisory-committees FDA will host a listening session in June as part of broader work to optimize the use of, and processes, for advisory committees. Mon, 29 Apr 2024 10:58:48 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-hold-listening-session-part-broader-work-optimize-use-and-processes-advisory-committees http://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests. Mon, 29 Apr 2024 09:50:43 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests http://www.fda.gov/news-events/press-announcements/fda-roundup-april-26-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 26 Apr 2024 15:08:58 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-26-2024 http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections Today, the FDA approved a new treatment for female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. Wed, 24 Apr 2024 13:32:13 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections http://www.fda.gov/news-events/press-announcements/fda-roundup-april-23-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 23 Apr 2024 15:20:02 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-23-2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-april-19-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 19 Apr 2024 16:19:55 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-19-2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-april-16-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 16 Apr 2024 14:56:33 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-16-2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-april-12-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 12 Apr 2024 13:41:05 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-12-2024 http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-philips-respironics-following-recall-certain-sleep The federal court entered a consent decree of permanent injunction against Philips Respironics following a recall of certain sleep therapy machines manufactured by the company. Tue, 09 Apr 2024 15:44:38 EDT FDA http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-philips-respironics-following-recall-certain-sleep http://www.fda.gov/news-events/press-announcements/fda-roundup-april-9-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 09 Apr 2024 15:30:54 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-9-2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-april-5-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 05 Apr 2024 14:51:44 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-5-2024 http://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses The FDA approved a new antibiotic for the treatment of certain patients with Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis; acute bacterial skin and skin structure infections; and community-acquired bacterial pneumonia. Wed, 03 Apr 2024 15:27:56 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses