FDA Clinical Inspection Summary: TMC435 (simepravir) submitted by Janssen

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for TMC435 (simepravir) submitted by Janssen. Four sites were inspected and site inspections ranged from four days to one week. One site received an FDA form 483.

Dr. Ferlizata was cited for:

  • Performing screening procedures on a subject who had not signed the IRB approved informed consent for the study. (FDA notes that the subject had signed consent for a sister study).