The California Department of Public Health notified the FDA about “multiple illnesses” related to consumers eating Frozen ...

The founding director of the FDA’s Office of Biotechnology writes that, with FDA approval of medications ultimately vested ...

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

Sea Win, Inc. of Los Angeles, CA, is recalling 650 cases of Frozen Half Shell Oysters from South Korea, harvested on Jan. 30 ...

Three alleged fentanyl dealers – including a brother and sister – are facing decades in prison for their roles in a major ...

Parents and pediatricians just gained one more tool to combat severe allergic reactions in young kids. San Diego-based ARS ...

Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.

Even though a majority of people on the streets do not use illegal drugs, they are both a factor leading to homelessness and ...

During a hearing, representatives for the Newsom administration said they could not provide a timeline for when ...

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

The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...