Steps that food manufacturers should take when responding to a food or dietary supplement incident, including investigating claims, assembling a response team, determining disposition of a food, and ...

A coalition of over 20 leading health organizations is calling on the U.S. Food & Drug Administration (FDA) to enforce ...

Makary, a prominent voice on U.S. health care practices throughout his career, spent 22 years at Hopkins Medicine ...

When FDA inspectors went to the Glenmark plant last month — five years after the agency’s prior inspection — they discovered problems with cleaning and testing that they said could affect ...

BioXcel Therapeutics (BTAI) announced that the U.S. Food and Drug Administration has concluded that the inspection of a single site in its TRANQUILITY II Phase 3 trial is closed under 21 C.F.R.20. ...

Dexcom, a medical device manufacturer that develops continuous glucose monitoring systems, received a warning letter from the FDA regarding manufacturing processes at its facilities in San Diego ...

Families around the U.S. faced major shortages of baby formula in 2022 after FDA inspections found bacteria linked to two infant deaths in Abbott's plant in Sturgis, Michigan. The factory's ...

While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...

Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...

When FDA inspectors went to the Glenmark plant last month — five years after the agency’s prior inspection — they discovered problems with cleaning and testing that they said could affect medicines ...

following an inspection conducted in August 2024. In an exchange filing released in the post market hours of February 27, the pharmaceutical company announced that the US FDA had issued the letter ...