New drug development: A regulatory overview

by Mark P. Mathieu, P. Mark 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 A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today,* 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.

500 pages, Paperback

First published March 1, 1987

Reviews

[Tierra Carbon]

A

[Brie · Rating 3 out of 5]

great overview of the industry and how a drug gets to market...

[Mary Jean · Rating 4 out of 5]

Read this book for a Regulatory Affairs class. Excellent source to keep handy. Could be a little better organized, and it could really use an index.