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.
"synopsis" may belong to another edition of this title.
This book provides the most comprehensive and up-to-date analysis of FDA's new drug development process available today. I recommend this well-written book for professionals engaged in the drug development and review process. --Biopharm Magazine
This book is superb! It is the single best source of information on the drug regulatory system. --Peter Barton Hutt, Covington & Burling
"About this title" may belong to another edition of this title.
Book Description Parexel Intl Corp, 2008. Hardcover. Book Condition: New. 8 Revised. Bookseller Inventory # DADAX1882615859
Book Description Parexel Intl Corp, 2008. Hardcover. Book Condition: New. Bookseller Inventory # P111882615859
Book Description Parexel Intl Corp, 2008. Hardcover. Book Condition: New. book. Bookseller Inventory # 1882615859
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. Hardcover. Book Condition: New. 1882615859 New Condition. Bookseller Inventory # NEW6.0858726