FDA 483 - Madeleine Duvic, M.D. - January 13, 2023

An FDA inspection of Madeleine Duvic, M.D., a clinical investigator in Houston, revealed significant deficiencies in the conduct of Study E7777-G000-302. Observations included a failure to timely report a serious adverse event to the sponsor, obtaining informed consent from a non-English speaking subject using an English document, and inadequate maintenance of dosing records. These issues indicate a lack of adherence to investigational plan requirements and informed consent regulations.