Do: Respond within 15 business days of the original letter and be specific in that response. “It’s important to critically ...

Jim Jones, director of the Food and Drug Administration’s food division, slammed the “indiscriminate firing” of dozens of his ...

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

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

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...