Clinical trial regulation is governed by the U.S. Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety and effectiveness of drugs, medical devices, and biologics. Clinical trials must be conducted in accordance with FDA regulations, …

Pharmacovigilance is the science and activities associated with the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. It is a cornerstone of medication safety and an important aspect of public …

Ensuring Drug Safety in Clinical Trials

Introduction

The conduct of clinical trials is essential to the development of new medicines. These trials are regulated by national laws and international conventions to ensure that the rights, safety and wellbeing of …