1) Researcher to annually self disclose financial COIs to the FDA.
2) Sponsors to annually disclose to the FDA financial COIs of researcher who conducted clinical studies.
3) Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.
4) Organizations to disclose financial COIs to the FDA no later than the time of submission of NDI application
The FDA regulations governing disclosure of individual COIs are:
*Researchers must make an annual self-declaration of financial COIs to the FDA
*Applicants submitting marketing applications must disclose financial COIs of researchers who performed the clinical studies
*Concerns to disclose to the FDAs their financial COIs soon after submitting the IND application
*Sponsors to make an annual declaration of the financial COIs of researchers who did the clinical studies to the FDA.
dont post such questions
nota=none of the above
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