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| The FDA’s CDER is responsible for ensuring drug safety and effectiveness in the United States. |
by Cindy Fazzi
Editor, MasterControl Insider
The U.S. FDA’s Center for Drug Evaluation and Research (CDER) is known worldwide as the office that approves innovative drugs, namely new molecular entities and new therapeutic biologics. Every year, the news media reports the number of novel drugs approved by CDER and the global impact of those medicines. But the center’s mission is much more than that. It ensures drug safety in the United States by regulating over-the-counter and prescription drugs, including biological therapeutics and generic drugs, and even such things as fluoride toothpaste and sunscreens (1).
MasterControl has announced that the company and its partner, i4DM, will serve as quality management system (QMS) providers for CDER’s Division of Pharmaceutical Analysis (DPA). The two companies are also the QMS providers for the FDA’s Office of Regulatory Affairs (ORA).
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