Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Report
Partner: UNT Libraries Government Documents Department