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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...
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.
WHAT'S BONUS TIME?
Normally, new semester rental orders are exactly 125 days.
With “Bonus Time” you can order early and get a FREE extension until 12/19*.
It’s our little way of rewarding you early renters for planning ahead.
But do hurry. The “Bonus Time” offer runs out on 8/8 (11PM PST).
* It can take up to 24 hours for the extension to appear in your account after you receive your textbooks.
Since launching the first textbook rental site in 2006, BookRenter has never wavered from our mission to make education more affordable for all students. Every day, we focus on delivering students the best prices, the most flexible options, and the best service on earth. On March 13, 2012 BookRenter.com, Inc. formally changed its name to Rafter, Inc. We are still the same company and the same people, only our corporate name has changed.