Author: Mark Mathieu
Edition: 8 Revised
Binding: Hardcover
ISBN: 1882615859
Edition: 8 Revised
Binding: Hardcover
ISBN: 1882615859
New Drug Development: A Regulatory Overview (New Drug Development ( Mathieu))
Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic.
Categories: Drugs->Law and legislation->United States, Drug development->United States. Contributors: Mark P. Mathieu - Author. Format: Hardcover
In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including:
* How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements.
* How the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes.
* How CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process.
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New Drug Development: Design, Methodology, and Analysis
New Drug Development: Design, Methodology, and Analysis: J. Rick Turner
Categories: Drugs->Law and legislation->United States, Drug development->United States. Contributors: Mark P. Mathieu - Author. Format: Hardcover
Categories: Drug development, Technology, Pharmaceutical. Contributors: Chandrahas Sahajwalla - Editor. Format: Hardcover
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