FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments. The QMM program aims to encourage drug manufacturers to implement quality management practices that go...
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...
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...
The FDA published a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality guidance from their Drug Evaluation and Research (CDER) program. This program facilitates submissions by external stakeholders and FDA staff...
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...