New Drug Development: A Regulatory Overview (NEW DRUG DEVELOPMENT ( MATHIEU))

New Drug Development: A Regulatory Overview (NEW DRUG DEVELOPMENT ( MATHIEU)) by Mathieu, Mark P.. hardcover edition. ISBN: 9781882615858.

Go inside the drug development and FDA regulatory process with todays 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 CDERs efforts to integrate a culture of drug safety has affected the centers structure and its new drug review and approval processes. * How CDERs much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDAs 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/biotechs go-to resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDAs drug development approval processes.