The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts ...
On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human ...
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate ...
FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...
Pharmaceutical consultants apply their comprehensive expertise in different areas to accelerate the drug development process.
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The Difference Between FDA And USDA Food Regulations, ExplainedWe've all seen the various inspection labels at the grocery store and heard news about food recalls. But what's the actual ...
FDA-approved drugs are also often patented and subject to various laws regarding exclusivity for a given manufacturer. At the ...
A U.S. federal judge has refused to allow compounding pharmacies to keep making copies of Eli Lilly's popular weight-loss and ...
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...
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