http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-roundup-march-31-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 31 Mar 2023 16:45:20 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-31-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray The U.S. Food and Drug Administration approved the first naloxone nasal spray product available without a prescription. Wed, 29 Mar 2023 08:28:42 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray http://www.fda.gov/news-events/press-announcements/fda-roundup-march-28-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 28 Mar 2023 15:25:04 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-28-2023 http://www.fda.gov/news-events/press-announcements/fda-outlines-immediate-national-strategy-further-increase-resiliency-us-infant-formula-market The FDA is releasing an immediate national strategy outlining actions the agency will take immediately to help ensure one of the nation’s most vulnerable populations continues to have access to safe, nutritious infant formula and to increase the resiliency of the U.S. infant formula market and suppl Tue, 28 Mar 2023 08:55:57 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-outlines-immediate-national-strategy-further-increase-resiliency-us-infant-formula-market http://www.fda.gov/news-events/press-announcements/fda-roundup-march-24-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 24 Mar 2023 15:27:52 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-24-2023 http://www.fda.gov/news-events/press-announcements/fda-works-further-improve-nutrition-reduce-diet-related-chronic-disease-dietary-guidance-statements FDA Works to Further Improve Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food Labels Fri, 24 Mar 2023 10:26:45 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-works-further-improve-nutrition-reduce-diet-related-chronic-disease-dietary-guidance-statements http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-aimed-improving-oncology-clinical-trials-accelerated-approval The FDA issued draft guidance to industry regarding clinical trial design and confirmatory studies to support accelerated approval applications in oncology. Fri, 24 Mar 2023 09:32:00 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-aimed-improving-oncology-clinical-trials-accelerated-approval http://www.fda.gov/news-events/press-announcements/fda-takes-additional-steps-improve-nutrition-reduce-disease-expanded-use-salt-substitutes-help-lower FDA proposes amending the standards of identity (SOIs) for foods that include salt as a required, or optional, ingredient to permit the use of safe and suitable salt substitutes. Fri, 24 Mar 2023 08:10:56 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-takes-additional-steps-improve-nutrition-reduce-disease-expanded-use-salt-substitutes-help-lower http://www.fda.gov/news-events/press-announcements/fda-roundup-march-21-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 21 Mar 2023 15:11:50 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-21-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-march-17-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 17 Mar 2023 17:22:48 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-17-2023 http://www.fda.gov/news-events/press-announcements/fda-denies-marketing-two-vuse-solo-menthol-e-cigarette-products The FDA issued marketing denial orders for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand. The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2. Fri, 17 Mar 2023 10:48:08 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-denies-marketing-two-vuse-solo-menthol-e-cigarette-products http://www.fda.gov/news-events/press-announcements/fda-authorizes-copenhagen-classic-snuff-be-marketed-modified-risk-tobacco-product The FDA authorized U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as a modified risk tobacco product (MRTP). Thu, 16 Mar 2023 11:40:29 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-authorizes-copenhagen-classic-snuff-be-marketed-modified-risk-tobacco-product http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-bivalent-pfizer-biontech-covid-19-vaccine-booster-dose The FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent Pfizer-BioNTech COVID- Tue, 14 Mar 2023 16:32:28 EDT FDA http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-bivalent-pfizer-biontech-covid-19-vaccine-booster-dose http://www.fda.gov/news-events/press-announcements/fda-roundup-march-14-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 14 Mar 2023 14:49:06 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-14-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-march-10-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 10 Mar 2023 15:49:10 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-10-2023 http://www.fda.gov/news-events/press-announcements/fda-seeks-72-billion-protect-and-advance-public-health-enhancing-food-safety-and-advancing-medical Today, the U.S. Food and Drug Administration announced it is requesting $7.2 billion as part of the president’s fiscal year (FY) 2024 budget. Thu, 09 Mar 2023 13:11:03 EST FDA http://www.fda.gov/news-events/press-announcements/fda-seeks-72-billion-protect-and-advance-public-health-enhancing-food-safety-and-advancing-medical http://www.fda.gov/news-events/press-announcements/fda-updates-mammography-regulations-require-reporting-breast-density-information-and-enhance Today, the FDA published updates to the mammography regulations to require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms. Thu, 09 Mar 2023 09:24:46 EST FDA http://www.fda.gov/news-events/press-announcements/fda-updates-mammography-regulations-require-reporting-breast-density-information-and-enhance http://www.fda.gov/news-events/press-announcements/fda-proposes-new-requirements-tobacco-product-manufacturing-practices The FDA is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. Wed, 08 Mar 2023 10:24:46 EST FDA http://www.fda.gov/news-events/press-announcements/fda-proposes-new-requirements-tobacco-product-manufacturing-practices http://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 07 Mar 2023 13:58:48 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-march-3-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 03 Mar 2023 15:16:56 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-3-2023