PharmExec2d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...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 Supra14h
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The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...
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The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones.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 ...
JD Supra8h
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 ...
News-Medical.Net1d
How consultants help accelerate drug product development timelines
Pharmaceutical consultants apply their comprehensive expertise in different areas to accelerate the drug development process.
Tasting Table on MSN2d
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 ...
CNET on MSN6d
Natural Medicine vs. FDA Drugs: Which Should You Use for Your Ailment?
FDA-approved drugs are also often patented and subject to various laws regarding exclusivity for a given manufacturer. At the ...
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 ...
DexCom receives warning letter from FDA, sees no impact to FY25 guidance
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...
RFK Jr. wants to eliminate FDA’s controversial food additive program. Here’s why that matters
It’s time to revamp the FDA’s “generally recognized as safe,” or GRAS, program that allows companies to add untested ...
WSPA Spartanburg on MSN3d
SC Bill could Affect Vaping Regulations
A new bill would, if passed, force businesses that sell vaping products to have guidelines and regulations about what can be ...