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

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

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

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

Dublin, Feb. 25, 2025 (GLOBE NEWSWIRE) -- The "What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained" training has been added to ResearchAndMarkets.com's offering.

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, ...

along with the applicable quality management systems. Imricor is executing a modular review process with the FDA, whereby ...

Dublin, Feb. 25, 2025 (GLOBE NEWSWIRE) -- The "What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained" training has been added to ResearchAndMarkets.com's offering. This ...

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

Researchers from the University of Colorado Anschutz Medical Campus studied a new method to deliver antibiotics, specifically ...

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 ...