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. * Which drug development strategies are fulfilling their promise and offering optimal * for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process. * How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions. * 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 CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new * are developed and regulated today, including: * How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements. "synopsis" may belong to another edition of this title.Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. * 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.įind 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. * 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. 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. * How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements. 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: Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic.
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