The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
We've all seen the various inspection labels at the grocery store and heard news about food recalls. But what's the actual ...
On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human ...
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
After years of weight loss drug shortages, the FDA is saying there's now an adequate supply for most medications and they ...
A U.S. federal judge has refused to allow compounding pharmacies to keep making copies of Eli Lilly's popular weight-loss and ...
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate ...
Pharmaceutical consultants apply their comprehensive expertise in different areas to accelerate the drug development process.
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.