New Drug Development: A Regulatory Overview (Revised Fifth Edition)

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.