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 ...
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
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 ...
22hon MSN
FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’ about his conduct
Dr. George Tidmarsh had been placed on leave Friday after Health and Human Services officials were notified of the issues, a ...
Executives from Eli Lilly, Merck and other companies foresee the FDA's new onshoring proposal being anything from a ...
This recall affects America’s most prescribed drug. It’s the latest in a series of concerning manufacturing issues that have ...
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 ...
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