On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...

FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...

Abbott has been hit with a slew of complaints from the FDA in a warning letter related to its continuous glucose monitor (CGM ...

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...

Abbott needs to conduct more performance testing to ensure its FreeStyle Libre devices are accurate, FDA inspectors found.

Aurobindo Pharma said the US FDA has completed its inspection at Eugia Pharma’s Unit-III formulation facility, issuing 11 ...

Some staff members say they are frustrated with the direction of inspections under new FDA Commissioner Dr Marty Makary. HealthDay News — The official in charge of federal food and drug safety ...

With every bottle of prescription medication comes an implied promise: The drugs are safe and effective and meet strict standards set by the Food and Drug Administration. But the agency known as one ...

The Food and Drug Administration (FDA) on Friday conducted coordinated compliance verification visits to major retail ...