The super antioxidant called ergothioneine or ErgoActive by ingredient supplier and manufacturer Blue California has achieved Generally Recognized as Safe (GRAS) status from the Food and Drug Administration (FDA) under its intended conditions of use.
The U.S. Food and Drug Administration approved an innovative treatment for scoliosis last week and it happens to have a fancy nickname. It’s called The Tether and it provides a fusion-less alternative for young patients requiring surgery.
Seventeen public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for September, the FDA reported.
The Eylea Injection Prefilled Syringe received the Chemistry, Manufacturing and Controls Prior-Approval Supplement by the Food and Drug Administration (FDA), according to a statement released by Regeneron Pharmaceuticals Inc.
The U.S. Food and Drug Administration (FDA) granted its Fast Track Designation to islaroxime, which is used for the treatment of acute heart failure. Islaroxime was developed by Windtree Therapeutics Inc., a biotechnology and medical device company.
The U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.
The Food and Drug Administration Office of Prescription Drug Promotion recently sent a letter to Aclaris due to false or misleading claims for its direct-to-consumer advertising for Eskata.
The Tobacco and Nicotine Products Regulation and Policy Conference will take place Oct. 24-25.
The pharmaceutical industry is looking at artificial intelligence (AI) to have a major impact on the future of medicine as relationships between pharma corporations and AI researchers are already flourishing in the hopes of one day providing a faster and more reliable digital health care service to patients around the nation.
The U.S. Food and Drug Administration periodically provides information on the pace of generic drug approvals through its website.
The multi-center PROACTIVE-HF trial of the Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) has been approved by the Food and Drug Administration (FDA). The point of the trial is to expedite pre-market approval (PMA) of the Cordella Sensor and provide evidence to the Centers for Medicare & Medicaid Services (CMS).
Diagnosing Lyme disease is notoriously difficult, so the announcement from the Food and Drug Administration (FDA) that four cleared tests with new indications are now cleared for marketing brings hope to the many who suffer from the disease.
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
President of the Board for The Consumer Advocates for Smoke-free Alternatives Association (CASAA) Bruce Nye compares the Food and Drug Administration’s (FDA) recent $60 million dollar anti-vaping television campaign to “propaganda” and “sloganeering.”
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As the U.S. Food and Drug Administration (FDA) is being flooded with requests to allow CBD in food and supplements, marijuana advocacy groups are eager for federal regulators to monitor the marketplace to help establish some semblance of order.
Six public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for August, the FDA reported.
The U.S. Food and Drug Administration has set its sights on working to learn more about the safety of CBD and related products.
With the rise of e-cigarettes and other popular vape products being consumed by young people, government entities are scrambling to find a solution to address the problem.
Food producers carried out 30 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
The Food and Drug Administration has Fast Tracked a drug that could provide treatment for those who have Parkinson's Disease