Born In The U.S.? Advisory Panel To Weigh U.S. Applicability Of Data On Watson’s Prochieve
This article was originally published in The Pink Sheet Daily
Executive Summary
Pivotal trial of Columbia Laboratories, Inc. and Watson Laboratories, Inc.'s Prochieve (progesterone vaginal gel 8%) was designed to be global, but can the sponsor convince an FDA advisory panel that the results have domestic relevance?