FDA’s Informed Consent Regulations for Clinical Investigations

FDA published guidance to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This document provides general guidance on FDA’s regulatory requirements for...

Quality Systems, Part 2: Developing Effective CAPAs

By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc.  In Quality Systems, Part 1: Deviation Management and Investigations, we learned about deviation management and investigations. In this second part of the series, we will...

FDA Fiscal Year 2022 Report on the State of Pharmaceutical Quality

This report presents analyses that reveal insights about pharmaceutical manufacturers and their products. This information will enable FDA to better prevent and mitigate quality issues that may lead to drug shortages and supply chain vulnerability. Overall, this...