The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts ...

The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...

We've all seen the various inspection labels at the grocery store and heard news about food recalls. But what's the actual ...

USDA Secretary Rollins and HHS Secretary Kennedy announced that they are reviewing the current Dietary Guidelines for Americans report, which will be changed and released this year.

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...

The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...

FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”) [2] for Hemady ®, a drug indicated in combination with other anti-myeloma products for the treatment of ...

The Health Secretary wants to eliminate a provision that allows companies to self-affirm that food ingredients are safe.

A U.S. federal judge has refused to allow compounding pharmacies to keep making copies of Eli Lilly's popular weight-loss and ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.