Guidance Requires Harder Search for Investigator Conflicts

The FDA May 24 released a draft guidance on financial disclosure for clinical investigators that would require applicants seeking marketing approval of devices and drugs to conduct a much more thorough search for financial conflicts of interest than previously required. If an investigator cannot be located for the applicant to obtain financial information, the draft suggests making at least two phone calls, sending at least two certified letters, requiring contact information from the investigator’s former institution, getting the sponsor involved in the search for records, conducting internet searches and/or contacting professional associates.
Devices & Diagnostics Letter