A warning letter posted Tuesday by the Food and Drug Administration revealed quality control issues with Dexcom’s continuous glucose monitors. The FDA raised concerns with a design change to a ...

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs. FDA’s Center for Drug Evaluation ...

DexCom DXCM is facing regulatory scrutiny following a warning letter recently posted by the FDA. This could affect the approval of the company’s upcoming 15-day G7 continuous glucose monitor (CGM).

Aspen Biopharma has been hit with an FDA warning letter outlining multiple issues at the company’s production facility in the Indian city of Hyderabad, including poor building design that could ...

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). 1 With a nod to the late Eddie ...

They have lost more than 50% of their value over the past year. A month ago, the firm received a warning letter from the FDA over the condition of two of its manufacturing plants. Investopedia ...

The Food and Drug Administration on Tuesday released a warning letter that it sent to medical device company Dexcom on March 4 citing quality issues at the facilities responsible for testing its ...

The Food and Drug Administration's top vaccine regulator quit his post with a scathing resignation letter slamming the Health Secretary for 'valuing misinformation over truth and transparency'.

Three months after Rigby’s death, a warning came from the U.S. Food ... the concerns are probably founded and that the FDA issued its letter based upon enough reports,” Franklin said.