In 2007, the US Congress introduced legislation to regulate the approval of follow-on biopharmaceutical medicines. The legislation raised questions as to what constitutes products that are “comparable” versus “interchangeable,” and what period of exclusivity is attached to products in each category. PharmaNet Consulting professionals include former senior-level FDA officials at the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) who offer unique insight into the agency’s thinking on this important development.
PharmaNet professionals available for consultation on this topic include:
Executive Director, PharmaNet Consulting
Vice President, PharmaNet Consulting
Vice President, Scientific and Regulatory Affairs, Anapharm
Executive Director, PharmaNet Consulting
504 Carnegie Center, Princeton, NJ 08540