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class='content'><h2>FDA</h2><h3>Food and Drug Administration</h3><button onclick='javascript:ERX.navigate("http://www.fda.gov");'>Visit FDA</button></div></div></div></div><div id='' class='section center'><div class='holder'><div class='container'><div class='content'><div><div class='feeds'><ul><li><div class='item'><h3>FDA Roundup: January 10, 2025</h3><p>The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-roundup-january-10-2025' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-roundup-january-10-2025</small></a><br/><small>Fri, 10 Jan 2025 15:03:25 EST</small></div></li><li><div class='item'><h3>FDA Roundup: January 7, 2025</h3><p>The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-roundup-january-7-2025' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-roundup-january-7-2025</small></a><br/><small>Tue, 07 Jan 2025 16:31:18 EST</small></div></li><li><div class='item'><h3>FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials</h3><p>The FDA issued draft guidance that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services. </p><a href='http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-including-tissue-biopsies-clinical-trials' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-including-tissue-biopsies-clinical-trials</small></a><br/><small>Mon, 06 Jan 2025 11:38:10 EST</small></div></li><li><div class='item'><h3>FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions</h3><p>The FDA issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. </p><a href='http://www.fda.gov/news-events/press-announcements/fda-proposes-framework-advance-credibility-ai-models-used-drug-and-biological-product-submissions' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-proposes-framework-advance-credibility-ai-models-used-drug-and-biological-product-submissions</small></a><br/><small>Mon, 06 Jan 2025 10:28:18 EST</small></div></li><li><div class='item'><h3>FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices</h3><p>Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-issues-comprehensive-draft-guidance-developers-artificial-intelligence-enabled-medical-devices' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-issues-comprehensive-draft-guidance-developers-artificial-intelligence-enabled-medical-devices</small></a><br/><small>Mon, 06 Jan 2025 10:16:00 EST</small></div></li><li><div class='item'><h3>FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones</h3><p>The FDA published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care used to estimate the amount of oxygen carried in the blood – across the range of skin pigmentation.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-proposes-updated-recommendations-help-improve-performance-pulse-oximeters-across-skin-tones' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-proposes-updated-recommendations-help-improve-performance-pulse-oximeters-across-skin-tones</small></a><br/><small>Mon, 06 Jan 2025 09:04:08 EST</small></div></li><li><div class='item'><h3>FDA Roundup: January 3, 2025</h3><p>The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-roundup-january-3-2025' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-roundup-january-3-2025</small></a><br/><small>Fri, 03 Jan 2025 14:19:21 EST</small></div></li><li><div class='item'><h3>FDA Roundup: December 27, 2024</h3><p>The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-roundup-december-27-2024' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-roundup-december-27-2024</small></a><br/><small>Fri, 27 Dec 2024 15:22:23 EST</small></div></li><li><div class='item'><h3>FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products</h3><p>FDA announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products</p><a href='http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-require-standardized-testing-methods-detecting-and-identifying-asbestos-talc' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-require-standardized-testing-methods-detecting-and-identifying-asbestos-talc</small></a><br/><small>Thu, 26 Dec 2024 12:08:07 EST</small></div></li><li><div class='item'><h3>FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes</h3><p>FDA approved the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes</small></a><br/><small>Mon, 23 Dec 2024 11:24:49 EST</small></div></li><li><div class='item'><h3>FDA Approves First Medication for Obstructive Sleep Apnea</h3><p>Today, the FDA approved the first medication for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity. </p><a href='http://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea</small></a><br/><small>Fri, 20 Dec 2024 17:03:40 EST</small></div></li><li><div class='item'><h3>FDA Roundup: December 20, 2024</h3><p>The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-roundup-december-20-2024' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-roundup-december-20-2024</small></a><br/><small>Fri, 20 Dec 2024 14:28:04 EST</small></div></li><li><div class='item'><h3>FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities</h3><p>FDA approved Symvess, the first acellular tissue engineered vessel for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-approves-first-acellular-tissue-engineered-vessel-treat-vascular-trauma-extremities' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-approves-first-acellular-tissue-engineered-vessel-treat-vascular-trauma-extremities</small></a><br/><small>Fri, 20 Dec 2024 09:25:00 EST</small></div></li><li><div class='item'><h3>FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers</h3><p>FDA announced a final rule to update the definition of the nutrient content claim “healthy” marking an important step in the agency’s nutrition priorities, which are part of a broader, whole-of-government approach to help address an ever-growing epidemic of preventable diet-related chronic diseases.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-updates-healthy-claim-providing-refreshed-tool-consumers' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-updates-healthy-claim-providing-refreshed-tool-consumers</small></a><br/><small>Thu, 19 Dec 2024 11:39:17 EST</small></div></li><li><div class='item'><h3>FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease</h3><p>FDA approves Ryoncil, the first mesenchymal stromal cell (MSC) therapy for treatment of steroid-refractory acute graft-versus-host disease (SR-a GVHD) in pediatric patients 2 months of age and older.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host</small></a><br/><small>Wed, 18 Dec 2024 16:40:14 EST</small></div></li><li><div class='item'><h3>FDA Roundup: December 17, 2024</h3><p>The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-roundup-december-17-2024' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-roundup-december-17-2024</small></a><br/><small>Tue, 17 Dec 2024 16:20:09 EST</small></div></li><li><div class='item'><h3>FDA Approves New Treatment for Congenital Adrenal Hyperplasia</h3><p>Today, the FDA approved a new treatment to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-congenital-adrenal-hyperplasia' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-congenital-adrenal-hyperplasia</small></a><br/><small>Fri, 13 Dec 2024 17:53:08 EST</small></div></li><li><div class='item'><h3>FDA Roundup: December 13, 2024</h3><p>The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-roundup-december-13-2024' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-roundup-december-13-2024</small></a><br/><small>Fri, 13 Dec 2024 14:33:24 EST</small></div></li><li><div class='item'><h3>FDA Roundup: December 10, 2024</h3><p>The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-roundup-december-10-2024' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-roundup-december-10-2024</small></a><br/><small>Tue, 10 Dec 2024 14:56:23 EST</small></div></li><li><div class='item'><h3>FDA Roundup: December 6, 2024</h3><p>The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.</p><a href='http://www.fda.gov/news-events/press-announcements/fda-roundup-december-6-2024' target='_blank'><small>http://www.fda.gov/news-events/press-announcements/fda-roundup-december-6-2024</small></a><br/><small>Fri, 06 Dec 2024 15:08:29 EST</small></div></li></ul></div><div class='clearfix'></div><div><p class='disclaimer'>The views and opinions expressed in this feed are those of the authors and do not									necessarily reflect the official policy or position of Elizabeth Pharmacy. 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