If drug tariffs don’t work, they could result in higher prices for American patients and increase drug shortages. Testing ...
To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...
Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
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 ...
Indian Pharmaceutical Alliance says the study relies on FDA Adverse Event Reporting System data, which captures link between ...
The warning letter identified issues in manufacturing processes and quality management system at Dexcom's facilities in San ...
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, ...
IPA also refuted the study's reliance on the FDA Adverse Event Reporting System (FAERS) data, stating that FAERS data is ...
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 ...