Tag 'Drug Safety'

U.S. Food and Drug Administration issued a final guidance for industry titled Postapproval Pregnancy Safety Studies on May 8, 2026. The guidance provides recommendations on…

In the evolving landscape of pharmacovigilance, signal management has become a central pillar in ensuring drug safety and maintaining compliance with global regulatory affairs…

Ensuring business continuity in pharmacovigilance operations is essential for safeguarding public health by continuously monitoring the safety of medicinal products. Any disruption in PV…

Drug safety, is a critical component of the healthcare and pharmaceutical industries. It focuses on detecting, assessing, understanding, and preventing adverse effects or any…

The U.S. Food and Drug Administration announced on March 11, 2026, the launch of a new unified platform for analyzing adverse event reports. The…

Under the EU Good Pharmacovigilance Practices (GVP), Marketing Authorization Holders (MAHs) are required to maintain a fully functioning, compliant, and continuously monitored Pharmacovigilance (PV)…

China’s (NMPA) has announced enhanced regulatory measures following the formal revision of the Implementing Regulations of the Drug Administration Law. The updated rules were promulgated…