New Drug Development: A Regulatory Overview

Mark P. Mathieu

Anne G. Evans

Eric L. Hurden

Health, Fitness & Dieting

Parexel Intl Corp

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.

New Drug Development : A Regulatory Overview

See the best price to sell, buy, or rent books by Anne G. Evans. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Anne G. Evans

See the best price to sell, buy, or rent books by Anne G. Evans. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

New Drug Development: A Regulatory Overview

New Drug Development : A Regulatory Overview