8th Edition of 'New Drug Development
Posted on: Friday, 7 March 2008, 12:00 CST
Research and Markets (http://www.researchandmarkets.com/reports/c85102) has announced the addition of New Drug Development: A Regulatory Overview (8th Edition) to their offering.
New Drug Development: A Regulatory Overview
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.
Reviews:
"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 Maga
"This book is superb! It is the single best source of information on the drug regulatory system."
--Peter Barton Hutt, Covington & Burling
For more information visit http://www.researchandmarkets.com/reports/c85102
Source: Business Wire
Related Articles
- ImClone and Bristol-Myers Squibb's Cancer Drug sBLA Wins FDA Priority Review
- FDA to Review FHC's Premarket Approval Application for Female Condom
- Pharsight Uses FDA Disease Model to Support Oncology Drug Development
- New Book Acquaints Students and Practitioners in the Intricacies of New Drug Development
- European Union Meeting Performance Goals for New Drug Review, but Lags Behind U.S. In New Drug Availability, According to Tufts Center for the Study of Drug Development
- FDA Puts Its Stamp of Approval on Merck's New Diabetes Drug
- Amgen cancer drug panitumumab gets FDA priority review
- FDA calls for studies to aid drug development
- No Link Between Drug Safety in U.S. And Approval Speed, According to Tufts Center for the Study of Drug Development
 |
 |
User Comments (0)
RSS Feeds