Advising Clients on Regulatory Approvals in the Life Sciences Industry

This 12-page summary report written for life science companies walks its readers through the various stages of the regulatory approval process in the life sciences industry. From product development and regulatory to the final marketing and approval stage, the report provides an in-depth look into the product information that is required at each stage.

Other topics include:

• pharmaceuticals
• FDA
• Investigational New Drug applications
• New Drug Applications
• clinical trials
• compliance
• Congressional hearings
• Federal Trade Commission
• protecting intellectual property
• and the political process

This Executive Report is written by:

• Diane J. Romza-Kutz, Managing Partner, Chicago & Stephen R. Drake, Attorney at Law, Epstein Becker & Green, P.C. - Seeking Approval in the Life Sciences Industry
• Walt Addison Linscott, Esq., Managing Partner, Atlanta; Chair, Life Sciences Practice, Thompson Hine LLP - The Regulatory Approval Process

About Executive Reports:

Executive Reports offer focused, hard-hitting advice from the leaders of some of America's top companies, packaged in a concise, readable format. Each research report provides readers with 3 to 5 strategies that will have a direct financial impact on their business. While not meant as a comprehensive guide, each report includes quick-hit items that can immediately impact specific business strategies. Executive authors drill down to the central issues surrounding each topic area and dispense expert advice in concise, direct language. Executive Reports feature leading professionals selected by the Aspatore Editorial Board based on their experience, research, and standing within the professional community.