Disqualification restriction and prosecution

From 1964 to 1999, 99 investigators were disqualified (via hearing process or consent agreement) and became ineligible to use investigational products; 26 investigators were restricted for a limited time to receive test article through adequate assurance to the FDA; and 20 investigators were prosecuted or convicted (through consent agreement).

In 1998, the FDA began issuing a new type of regulatory letter - the NIDPOE letter, where the investigator had repeatedly or deliberately failed to comply or had submitted false information to the FDA. A total of 11 NIDPOE letters have been issued in fiscal years 1998-2000.

The FDA has identified several cases in which there was submission of false information (deficiency code 17). From June 1977 to 30 September 2000, there was a total of 40 domestic and two foreign investigators who submitted false clinical information (Figure 7.8).

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