The FDA orders the recall of MediNatura nasal spray in the US after finding live microbes; immunocompromised patients are at ...

The U.S. FDA’s Jan. 14 webinar for the new Quality Management System Regulation included some fairly predictable content, but one member of the FDA staff mentioned that the agency now expects ...

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

In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to ...

Medical device manufacturers face a labyrinth of audit and inspection regimes, each with unique demands that can make global compliance feel like a high-stakes balancing act. This article examines the ...

Saudi regulator says penalties were imposed on pharmacies for breaches of the electronic Drug Track and Trace System ...

Pakistan’s drug regulator says digital reforms at DRAP have accelerated medicine approvals and improved access to quality ...

This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effe ...

The U.S. Food and Drug Administration may soon convert an entire generation of U.S. children, especially children in foster ...

Lord’s Mark Industries Ltd, one of India’s fastest-growing diversified conglomerates, has achieved a significant milestone by becoming one of the companies to secure US FDA registrations covering 153 ...

Stability is a critical factor in drug formulation, with implications for product quality, lifecycle management, and ...

ATH-063 is a novel, oral, first-in-class, small molecule therapeutic targeting both inflammation and direct mucosal healing in patients with ulcerative colitis and Crohn's disease LOS ANGELES, CA / ...