Strategies for Dispute Resolution with the US Food and Drug Administration.By Margaret and Andrew Uprichard.

摘要

Disputes during drug development between sponsors and division reviewers at the US Food and Drug Administration sometimes cannot be resolved at the division level. Under the guidance document on dispute resolution issued by the FDA in February 20001, a sponsor may in such cases appeal the disputes to higher levels within the agency. The dispute resolution process may take months to years; however, if a sponsor has a compelling data-based argument, and the tenacity to endure a long process, the outcome can be successful. Such is the case of the approval of Vasovist (gadofosveset trisodium), a contrast agent developed by EPIX Pharmaceuticals.