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FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews.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 ...
The FDA's top drug regulator, Dr. George Tidmarsh, quit after federal officials began reviewing "serious concerns about his ...
Parents and clinicians are urged to review usage of certain health products for young children after federal authorities ...
18hon MSN
FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’ about his conduct
The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government ...
Shortages to backbone chemotherapy drugs are negatively affecting patient care, and more shortages are likely without policy ...
This recall affects America’s most prescribed drug. It’s the latest in a series of concerning manufacturing issues that have ...
The Food and Drug Administration sent a warning letter to Philips last month due to quality violations found at three of its ...
FDA finds widespread quality issues at three Philips medical device facilities, citing violations in manufacturing and complaint handling.
5don MSN
FDA to streamline approvals for generic biological drugs in latest move targeting health costs
The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
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