Amy Cole

I enclose details of our latest New Drug Development Handbook.

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.

Better yet, this new edition has been expanded to address the most cutting-edge developments redefining how new drugs are developed and regulated today, including:

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, and

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 a complete copy of this report click on:
http://www.researchandmarkets.com/product/3847a2/new_drug_development_a_regulatory_overview

Pricing:

Hard Copy : EUR 155

Ordering - Three easy ways to place your order:

1] Order online at http://www.researchandmarkets.com/product/3847a2/new_drug_development_a_regulatory_overview

2] Order by fax: Print an Order form from http://www.researchandmarkets.com/product/3847a2/new_drug_development_a_regulatory_overview and Fax to +353 1 4100 980

3] Order by mail: Print an Order form from http://www.researchandmarkets.com/product/3847a2/new_drug_development_a_regulatory_overview and post to Research and Markets Ltd. Guinness Center, Taylors ***, Dublin 8. Ireland.

Thank you for your consideration.
Best Regards,

Amy Cole

Senior Manager

Research and Markets Ltd

amy.cole@researchandmarkets.com

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New Drug Development: A Regulatory Overview (7th Edition)