Home » FDA Oversight of Clinical Investigators’ Finances Needs Improvement, OIG Says
FDA Oversight of Clinical Investigators’ Finances Needs Improvement, OIG Says
Sponsors of clinical trials may receive greater scrutiny of their financial ties to clinical investigators following an HHS Office of Inspector General (OIG) report recommending the agency require sponsors to submit investigators’ complete financial information in pretrial applications and ensure its staff documents reviews and takes appropriate action. The FDA lacks a complete list of investigators, approves marketing applications with missing financial information and doesn’t tell its on-site Bioresearch Monitoring (BiMo) program inspectors to check for complete financial information from sponsors, the report says.
Clinical Trials Advisor
Clinical Trials Advisor
Upcoming Events
-
25Apr
-
07May
-
14May
-
30May