New drug approval in ... [name of country] (Worldwide pharmaceutical regulation series)

Parexel International Corporation

Parexel

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 (NEW DRUG DEVELOPMENT ( MATHIEU))

Science & Math

Mathieu, Mark P.

Evans, Anne G.

Biological Sciences

Barnett Educational Services / Chi

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