Life-science companies and allied organizations face a myriad of market and strategy-based challenges in their efforts to conduct clinical trials, obtain regulatory approval, gain market entry, and successfully market a drug therapy – due in part to an ever-changing competitive landscape; complex government regulations; pricing concerns; legislation updates. VOI helps plot a course for success with a series of publications and reports that elevate the reader’s understanding of a complex global marketplace.

AVAILABLE NOW: GenericHandbook - 3rd Edition (available January 2009).
This Guide to the Generic Drug Industry in the U.S. offers an in-depth analysis of regulations, markets, companies and products in the U.S. generic drug industry.

 

ORDER NOW: GenericHandbook - 2nd Edition in PDF download: Price: $350 
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Publication Highlights:

• New FDA and FTC regulations
• Analysis of recent court decisions on authorized generics, recent out-of-court settlements and Paragraph IV challenges
• Biogeneric developments in Europe and US
• Analysis of emerging providers in India, China and Eastern Europe
• Up-to-date patent and exclusivity information
• Analysis of Wal-Mart's $4 Generic Program

Product & Market Section: 
Five-year market forecast - Opportunity assessment for products losing patent 2006 - 2011 - Top 400 branded and generic products (sales and growth rates) - Patent & exclusivity data for every FDA-approved product - Top 20 therapeutic categories -Total category sales - Share by company within therapeutic category and MORE...

Regulatory Section: 
FDA structure and policies - Administrative actions and trends - Hatch-Waxman trends in case law - Paragraph IV challenges and success rates and MORE...

Company Section: 
Senior Executive contact information - Company strategy & therapeutic focus - Formulation capabilities - Drug Master Files (DMF's) - Ownership (public vs. private) Financial data (public companies) and MORE...

GenericHandbook - 2nd Edition in PDF download: Price: $350 
ORDER NOW (50% Savings)