http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-roundup-december-22-2023 FDA Roundup: December 22, 2023 Fri, 22 Dec 2023 12:20:22 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-22-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-december-19-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 19 Dec 2023 16:55:39 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-19-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-december-15-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 15 Dec 2023 15:13:08 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-15-2023 http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-pharmasol-distributing-adulterated-drugs The U.S. District Court for the District of Massachusetts entered a consent decree of permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company. Thu, 14 Dec 2023 13:30:46 EST FDA http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-pharmasol-distributing-adulterated-drugs http://www.fda.gov/news-events/press-announcements/joint-federal-operation-results-seizure-more-18-million-illegal-e-cigarettes Today, the U.S. Food and Drug Administration, in collaboration with U.S. Customs and Border Protection (CBP), announced the seizure of approximately 1.4 million units of unauthorized e-cigarette products. Thu, 14 Dec 2023 10:44:40 EST FDA http://www.fda.gov/news-events/press-announcements/joint-federal-operation-results-seizure-more-18-million-illegal-e-cigarettes http://www.fda.gov/news-events/press-announcements/fda-warns-nine-manufacturers-distributors-unapproved-antimicrobials-animals The FDA is announcing the issuance of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations of federal law. Thu, 14 Dec 2023 08:59:19 EST FDA http://www.fda.gov/news-events/press-announcements/fda-warns-nine-manufacturers-distributors-unapproved-antimicrobials-animals http://www.fda.gov/news-events/press-announcements/fda-advances-reorganization-proposal-unified-human-foods-program-field-operations-and-additional The FDA is providing an update on its efforts to create a unified Human Foods Program and new ORA model, including additional details about the proposed structure, status of activities and timeline for next steps. Wed, 13 Dec 2023 12:58:20 EST FDA http://www.fda.gov/news-events/press-announcements/fda-advances-reorganization-proposal-unified-human-foods-program-field-operations-and-additional http://www.fda.gov/news-events/press-announcements/fda-creates-new-advisory-committee-evaluation-genetic-metabolic-disease-treatments The FDA is creating a new advisory committee related to potential treatments for genetic metabolic diseases. Genetic metabolic diseases are conditions that disrupt an individual's metabolism, which is the chemical process responsible for converting food into energy and eliminating toxins from the bo Tue, 12 Dec 2023 09:49:57 EST FDA http://www.fda.gov/news-events/press-announcements/fda-creates-new-advisory-committee-evaluation-genetic-metabolic-disease-treatments http://www.fda.gov/news-events/press-announcements/fda-roundup-december-8-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 08 Dec 2023 14:10:39 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-8-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years and older. One of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology. Fri, 08 Dec 2023 11:10:51 EST FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease http://www.fda.gov/news-events/press-announcements/fda-roundup-december-5-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 05 Dec 2023 16:59:37 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-5-2023 http://www.fda.gov/news-events/press-announcements/fda-usda-and-epa-propose-national-strategy-reduce-us-food-loss-and-waste FDA, USDA and EPA release draft strategy to prevent the loss and waste of food and increase recycling of organics to support a circular economy for all, reduce greenhouse gas emissions, save households and businesses money, and build cleaner communities Mon, 04 Dec 2023 09:04:50 EST FDA http://www.fda.gov/news-events/press-announcements/fda-usda-and-epa-propose-national-strategy-reduce-us-food-loss-and-waste http://www.fda.gov/news-events/press-announcements/fda-roundup-december-1-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 01 Dec 2023 16:46:57 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-1-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-november-28-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 28 Nov 2023 16:24:59 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-november-28-2023 http://www.fda.gov/news-events/press-announcements/fda-cautions-public-safety-issue-philips-dreamstation-2-cpap-machines The FDA is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics’ DreamStation 2 Continuous Positive Airway Pressure (CPAP) machines used for treatment of obstructive sleep apnea Tue, 28 Nov 2023 15:36:57 EST FDA http://www.fda.gov/news-events/press-announcements/fda-cautions-public-safety-issue-philips-dreamstation-2-cpap-machines http://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-type-non-cancerous-tumors The FDA approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Nirogacestat is a new molecular entity and the first drug to be approved for the treatment of patients with desmoid tumors, a subtype of soft tissue sarcomas. Mon, 27 Nov 2023 17:32:36 EST FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-type-non-cancerous-tumors http://www.fda.gov/news-events/press-announcements/fda-roundup-november-21-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 21 Nov 2023 15:51:25 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-november-21-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-november-17-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 17 Nov 2023 16:18:18 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-november-17-2023 http://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decrees-against-utah-based-dietary-supplement-distributor-and A dietary supplement distributor, dietary supplement manufacturer, and two executives have been ordered by a federal court to stop selling Balance of Nature products Thu, 16 Nov 2023 10:36:25 EST FDA http://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decrees-against-utah-based-dietary-supplement-distributor-and http://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection Today, the FDA granted marketing authorization of first diagnostic test for chlamydia and gonorrhea with at-home sample collection. Wed, 15 Nov 2023 15:46:28 EST FDA http://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection