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Article: `Global' review of drug master files hits packaging manufacturers. (Regulatory Analysis).(packaging of drugs, US Food and Drug Administration)(Brief Article)
- Article from:
- Food & Drug Packaging
- Article date:
- September 1, 2002
- Author:
CopyrightCOPYRIGHT 2002 BNP Media. 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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The U.S. Food and Drug Administration (FDA) has initiated "global" reviews of Drug Master Files (DMFs). FDA's Center for Drug Evaluation and Research (CDER) began this new practice to achieve consistency in the information in DMFs.
It is, however, causing consternation for DMF holders of packaging materials.
The DMF system provides relevant information to FDA about facilities, processes or articles used in the manufacture, processing, packaging and storage of human drug products, when such information is considered confidential by its owner. Many packaging materials suppliers use DMFs to provide information to FDA about the safety and suitability of ...