Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...

The FDA’s restraints on food ingredients are limited and relatively feeble, especially compared with those in Europe, a KFF Health News examination found.

Archimedic has unveiled OpenQMS, a free, web-based platform designed to help medtech companies efficiently manage Quality ...

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

THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...

DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response.

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...

The FDA cited issues with DexCom’s response to prior inspection findings, known as Form 483 observations. The inspections took place at the San Diego facility between October 21 and November 7, 2024, ...

If drug tariffs don’t work, they could result in higher prices for American patients and increase drug shortages. Testing ...

QIAGEN N.V. QGEN has secured FDA clearance for its QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, bolstering its syndromic testing portfolio in the United States. This marks the ...

Chemicals such as titanium dioxide and potassium bromate, whose safety has been debated, are allowed in foods in the United ...