PharmExec3d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
JD Supra1d
FDA Guidance for Labeling Plant-based Products
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...
MedTech Dive4d
New FDA pulse oximetry guidelines could stall under Trump
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts ...
Tasting Table on MSN3d
The Difference Between FDA And USDA Food Regulations, Explained
We've all seen the various inspection labels at the grocery store and heard news about food recalls. But what's the actual ...
JD Supra5h
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
US judge denies injunction, restricting copies of Lilly weight-loss drug
A U.S. federal judge has refused to allow compounding pharmacies to keep making copies of Eli Lilly's popular weight-loss and ...
BioSpace9d
FDA, Other Experts Seek to Redefine Obesity and Prioritize Maintenance Treatment
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate ...
Drug Delivery Business4d
Dexcom receives FDA warning letter
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
MedTech Dive4d
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...