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 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:…
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 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…
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
The FDA issued draft guidance that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials evaluating investigational medical products and/or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The FDA issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life…
The FDA published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care used to estimate the amount of oxygen…