Risks to Your Investigational Product Research

Risks During Research

FDA Rejection Letter – Eliquis_complete_response_letter

FDA believed further investigation into the true rate of dispensing errors was warranted. Furthermore, agency reviewers seemed  incredulous that the unusual number of medication errors failed to prompt a “serious inquiry” by the sponsor prior to NDA submission and that such errors occurred throughout the course of the trial without meaningful corrective measures, suggesting shortfalls in trial oversight.