Latest Updates & News
FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials.The draft guidance is intended, when finalized, to assist industry, clinical investigators,...
FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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. This is the first guidance the agency has issued on the use of AI for the...
FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle. The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for...
FDA Roundup: December 27, 2024
For Immediate Release: December 27, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA announced recommended changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder. The recommended changes intend to encourage the submission of...
FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
For Immediate Release: December 23, 2024 Today, the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, 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...
FDA Approves First Medication for Obstructive Sleep Apnea
For Immediate Release: December 20, 2024 Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity. “Today’s approval marks the first drug treatment option for certain...