Research and Markets - Cutting-edge Developments are Redefining how New Grugs are Developed and Regulated Today

Research and Markets (researchandmarkets.com/reports/c9752) has announced the addition of New Drug Development: A Regulatory Overview (7th Edition) to their offering.

(PRWEB) November 22, 2004 -- Research and Markets (http://www.researchandmarkets.com/reports/c9752) has announced the addition of New Drug Development: A Regulatory Overview (7th Edition) to their offering.

New Drug Development: A Regulatory Overview brings you inside each step of the drug development and FDA review process, from pre-clinical testing to post-approval reporting requirements.This overview considers the most cutting-edge developments redefining how new drugs are developed and regulated today.

Issues discussed in this report include:

How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decision makers.

Which strategies are fulfilling their promises 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,

What implications FDA initiatives in risk management/drug safety, good review management, and systems quality are holding for drug development programs and new drug reviews.

How the FDA's pending reorganization will affect drug reviews going forward

What ways the common technical document (CTD) format and electronic submissions are reshaping marketing applications in the United States now that they have gained significant momentum.

For more information visit http://www.researchandmarkets.com/reports/c9752

Laura Wood

Senior Manager

Research and Markets

press@researchandmarkets.com

Fax: +353 1 4100 980

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