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Article: Pharmaceutical cGMPs for the 21st century: a risk-based approach: progress report: proposed process for dispute resolution. (Market Research Studies).
- Article from:
- Biomedical Market Newsletter
- Article date:
- January 1, 2003
CopyrightCOPYRIGHT 2003 Biomedical Market Newsletter, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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US Food & Drug Administration
Feb. 27, 2003
I. Introduction
* In Aug. 2002, FDA announced a new initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach." The initiative focuses, in part, on FDA's current Good Manufacturing Practice (cGMP) program and covers the manufacture and product quality of veterinary and human drugs, including human biological products.
* The Dispute Resolution Working Group was formed as part of the initiative. The working group comprises representatives from the Office of Regulatory Affairs (ORA), Center for Drug Evaluation & Research (CDER), Center for Biologics Evaluation & Research (CBER), and ...