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New Drug Development: A Regulatory Overview (7th Edition)

- $145.00

Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic - New Drug Development: A Regulatory Overview.

Better yet, this new edition has been expanded to address the most cutting-edge developments redefining how new drugs are developed and regulated today, including:

  • How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions.
  • Which strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process.
  • What implications FDA initiatives in risk management/drug safety, good review management, and systems quality are holding for drug development programs and new drug reviews.
  • How the FDA's pending reorganization will affect drug reviews going forward.
  • What ways the common technical document (CTD) format and electronic submissions are reshaping marketing applications in the United States now that they have gained significant momentum.

Reader Testimonials:

"This book provides the most comprehensive and up-to-date analysis of FDA's new drug development process available today. I recommend this well-written book for professionals engaged in the drug development and review process."
Biopharm Magazine

"This book is superb!. It is the single best source of information on the drug regulatory system."
Peter Barton Hutt, Covington & Burling

Find out why New Drug Development is pharma/biotech's "go-to" resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes.

Edited by Mark Mathieu, PAREXEL International.
389 pages, ISBN 1-882615-72-7. Hardcover. December 2004.