PharmExec4d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...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 Supra2d
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The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...
JD Supra2d
FDA, OHRP Issue Joint Guidance on Collection of Tissue Biopsies in Clinical Trials
On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human ...
MedTech Dive5d
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The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones.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 ...
Compound versions of some weight loss drugs to be restricted
Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to treat Type 2 diabetes. Some doctors also prescribe Mounjaro "off-label" for ...
BioSpace11d
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 ...
KFF Health News2d
FDA Gives 2025-26 Flu Shot Guidance, Minus Input From Advisory Committee
After studying this year's influenza information, the recommendation is that flu vaccines for next year be trivalent, reports CNN. Also in the news, Vermont reports its first measles case in a ...
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 ...
Kennedy asks FDA to revise rules for food ingredient safety
U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. on Monday directed the Food and Drug Administration to ...