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FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
RFK Jr. Wants to Close a Controversial FDA Loophole in Food Additive Regulation
The FDA’s GRAS rule lets companies decide if food additives are safe—without agency oversight. RFK Jr. now aims to close this ...
JD Supra6h
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 ...
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The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...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The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones.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 ...
Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
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.
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 ...
FDA recognizes need for immunogenicity assays in therapeutics with carriers or conjugates
A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration ...