The FDA issued draft guidance that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials evaluating investigational medical products and/or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…
The FDA issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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…
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life…
The FDA published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care used to estimate the amount of oxygen…
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis Source: FDA Drug Safety Podcasts
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
FDA announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products Source: FDA Press Releases
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…
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…