New Drug Development

Author: Mark Mathieu
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. 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.

* Categories: Drugs->Law and legislation->United States, Drug development->United States. Contributors: Mark P. Mathieu - Author. Format: Hardcover Read medical textbooks online like New Drug Development here

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