This report provides the guidance offered by the FDA, and explains how it can be deployed to develop effective new treatments. The report also addresses the remaining barriers to development and provides insight into co-development trials as well as discussing commercial factors such as anti-trust, intellectual property and working across different corporate cultures.
The report includes:
• A concise overview of where codevelopment currently sits and what lies ahead
• Insight into the FDA guidance and how it can be applied
• Explanation of the FDA's regulatory approach
• Examination of legal challenges presented by working collaboratively across companies
• Four cases studies of companies actively codeveloping or have the potential to do so
• Overview of non-regulatory issues, such as antitrust, financials, intellectual property and corporate culture
For more information and to purchase this Insight Pharma Report, visit: http://www.InsightPharmaReports.com
About Insight Pharma Reports
Insight Pharma Reports are written by experts in consulting and industry who collaborate with us to provide a series of reports that evaluate the salient issues in pharmaceutical technology, business, and therapy markets. Insight Pharma Reports are used by leading pharmaceutical, biotech, diagnostic, consulting, and financial companies to keep abreast of the latest advances in pharmaceutical R&D, their potential applications and business impacts, and their current and future position in the marketplace. Insight Pharma Reports is a division within Cambridge Healthtech Institute. http://www.InsightPharmaReports.com
Insight Pharma Reports offers our Affiliated Reports Collection which provides a repository of additional scientific and business resources. For more information, visit http://www.insightpharmareports.com/
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Insight Pharma Reports are written by experts in consulting and industry who collaborate with us to provide a series of reports that evaluate the salient issues in pharmaceutical technology, business, and therapy markets.