A top vaccine official at the Food and Drug Administration (FDA) resigned, citing Health and Human Services (HHS) Secretary ...

Data from the ATLAS research comprises a series of trials that have yielded years of long-term, comprehensive data on safety ...

SAN DIEGO – Dexcom has received a warning letter from the U.S. Food and Drug Administration regarding “non-conformities” in manufacturing and quality processes after inspections of its facilities ...

Jiangsu Hengrui Pharmaceuticals and its partner Elevar Therapeutics will have to wait even longer before their PD-1 inhibitor ...

It’s the second consecutive no-finding inspection at Unit-2, further reinforcing the company’s commitment to regulatory ...

A warning letter usually comes after a Form 483 is issued. Form 483s are used by the FDA after inspections to communicate conditions that may violate the Food Drug and Cosmetic (FD&C) Act. Companies ...

The inspection covered both clinical and bioanalytical phases of three Bioavailability and Bioequivalence (BA/BE) studies submitted by clients, to the US Food and Drug Administration (FDA). The ...

noted "deficiencies in the response" from DexCom to the FDA's Form 483, which outlines observations from investigators. The company noted the FDA held inspections of its San Diego, Calif., ...

The new admonition came after the FDA found deficiencies in Dexcom’s response to the inspections’ official list of observations, known as a Form 483. According to the agency, some of those ...

FDA inspectors visited Dexcom’s facility in Mesa, Arizona, in June and its San Diego site in October and November. The inspections generated a Form 483 that listed observations the FDA made during its ...