|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).
DPA will be adopting MasterControl’s full QMS to manage documents, training records, audits, CAPAs, change control, and other quality processes. The division plays a crucial role in fulfilling CDER’s mission to ensure the safety of over-the-counter and prescription drugs, including biological therapeutics and generic drugs (2).
“MasterControl is excited to expand its existing project with FDA by adding the Center for Drug Evaluation and Research to its quality management platform,” said Matt Lowe, MasterControl executive vice president. “MasterControl’s mission to get lifesaving products to market sooner is well aligned with that of FDA and specifically CDER as it pertains to new pharmaceuticals.”(3)
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Second FDA Division
DPA is the second FDA division to implement MasterControl. ORA, the lead entity for all of the FDA’s field activities, bought MasterControl software in 2009 as the tool for its quality managers to uniformly apply and monitor ORA work products and processes.
ORA’s business units use MasterControl for core procedures, such as document control and audit, while i4DM provides program management, security consulting, and integration services to the office (4).
Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.
(1) To read more about CDER, go to:
(2) To read about DPA, go to: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm136991.htm
(3) To read the announcement about MasterControl’s role as QMS provider for DPA, go to: http://www.mastercontrol.com/news/2015/mastercontrol_fda_qms_provider.html
(4) To read the announcement about ORA’s QMS providers, go to: http://www.businesswire.com/news/home/20141112005257/en/MasterControl-Continues-Role-QMS-Provider-FDA%E2%80%99s-Office#.VGTDQU1OW71