FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews.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

The Food and Drug Administration (FDA) has put four companies on notice for marketing “unapproved fluoride-containing ingestible drugs” for use by children under the age of 3 or children at low or ...

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

The FDA has sent Philips a warning letter over three ultrasound and enterprise informatics facilities in the U.S. and the Netherlands.

A popular BBQ sandwich has been recalled over a potential choking hazard. E.A. Sween has issued a recall on 127,887 pounds of ...