Pharmacovigilance

Pharmacovigilance

FDA’s Final Rule on ACNU and updated postmarking safety reporting requirements for Nonprescription Drugs

The FDA’s final rule on nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU) introduces significant updates to postmarketing safety and reporting requirements goes into effect on January 27, 2025. These changes aim to enhance clarity, streamline reporting obligations, and ensure the ongoing safety of these drugs in …

Regulatory updates

Beyond Drugs: The Evolving Scope of Pharmacovigilance in Modern Healthcare

Pharmacovigilance is a critical component of healthcare systems worldwide, ensuring the safety and efficacy of medical products across their entire lifecycle—from development to post-market use. Traditionally, pharmacovigilance has been most closely associated with monitoring the safety of pharmaceutical drugs involving the detection, assessment, understanding, and prevention of adverse effects or …

Introduction