Advising Clients on Regulatory Approvals in the Life Sciences Industry The Over-arching Issues You Need to Know

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: 1. 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" 2. Walt Addison Linscott, Esq., Managing Partner, Atlanta; Chair, Life Sciences Practice, Thompson Hine LLP - "The Regulatory Approval Process"Romza-Kutz, Diane J. is the author of 'Advising Clients on Regulatory Approvals in the Life Sciences Industry The Over-arching Issues You Need to Know', published 2006 under ISBN 9781596225725 and ISBN 1596225726.