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. ![]() Drug Discovery and Development cpb us e1. test the new compound in the lab and clinic for safety and efficacy and gain approval and get the new drug into the hands of doctors and patients. Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. DOWNLOAD New Drug Development A Regulatory Overview (New Drug Development ( Mathieu)) PDF Online.
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