Archive for January 2025
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic to treat moderate to severe acute pain in adults. Source: FDA Press Releases
Read MoreFDA Roundup: January 17, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
Read MoreFDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review
Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. Source: FDA Press Releases
Read MoreFDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. Source: FDA Press Releases
Read MoreFDA Roundup: January 14, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
Read MoreFDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods
FDA announces a proposed rule requiring food manufacturers to display a front-of-package (FOP) nutrition label on most packaged foods. The proposed FOP nutrition label, referred to as the Nutrition Info box, would display nutrition information interpreting the saturated fat, sodium, and added sugars Source: FDA Press Releases
Read MoreFDA Roundup: January 10, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
Read MoreFDA Roundup: January 7, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
Read MoreFDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
The FDA issued draft guidance that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials evaluating investigational medical products and/or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. Source: FDA Press Releases
Read MoreFDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
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. Source: FDA Press Releases
Read More