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.
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Book Description Parexel Intl Corp. Hardcover. Book Condition: New. 8 Revised. Bookseller Inventory # DADAX1882615859
Book Description PAR, 2008. Hard Cover. Book Condition: New. brand new book. Bookseller Inventory # 011558
Book Description Barnett Educational Services / Chi, 2008. Hardcover. Book Condition: Brand New. 8th revised edition. 362 pages. 10.75x8.50x1.25 inches. In Stock. Bookseller Inventory # 1882615859
Book Description Parexel Intl Corp, 2008. Book Condition: New. Brand New, Unread Copy in Perfect Condition. A+ Customer Service!. Bookseller Inventory # ABE_book_new_1882615859