Parents and clinicians are urged to review usage of certain health products for young children after federal authorities ...

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

The notice follows inspections of three Philips facilities that found failures to meet standards for reporting complaints and ...

The U.S. Food and Drug Administration has flagged three of Philips' medical device facilities after inspections found they ...

Dr. George Tidmarsh had been placed on leave Friday after Health and Human Services officials were notified of the issues, a ...

FDA finds widespread quality issues at three Philips medical device facilities, citing violations in manufacturing and complaint handling.

The Food and Drug Administration sent a warning letter to Philips last month due to quality violations found at three of its ...

The U.S. Food and Drug Administration (FDA) has sent Royal Philips CEO Roy Jakobs a warning letter saying the devices made at three of its facilities are adulterated and fail to conform ...

For decades, the agency has redacted drug names from reports. Now, several former officials support ending the practice.

Shortages to backbone chemotherapy drugs are negatively affecting patient care, and more shortages are likely without policy ...

The FDA's drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the ...