New Drug Development: A Regulatory Overview
Author: Mark Mathieu
Affiliation:
Publisher: Barnett International
Publication Date: 2021
ISBN 10: 1882615859
ISBN 13: 9781882615858
eISBN: 9780111030042
Edition: 8th
Affiliation:
Publisher: Barnett International
Publication Date: 2021
ISBN 10: 1882615859
ISBN 13: 9781882615858
eISBN: 9780111030042
Edition: 8th
Description:
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. How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions. Which drug development 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. 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. Approx. 400 pages 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
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