The FDA regulations governing disclosures of individuals COIs require:
A: Researcher to annually self-disclose financial COIs to the FDA.
B: Sponsors to annually disclose to the FDA financial COIs of the researcher who conducted clinical studies.
C: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.
D: Organizations disclose financial COIs to the FDA no later than the time of submission of the NDI application.
The correct option is C.
The FDA regulations that govern the disclosure of individual COIs requires applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.
The FDA’s regulation requires applicants to submit marketing applications for biologics, drugs, or devices.
It requires them to certify the financial interests’ or to disclose the economic interests of those researchers who have conducted clinical studies governed by the regulation.
If a marketing application does not include certification or if it does not contain a discloser of the financial interests of the researchers, then FDA may reject to file the appeal. It means that FDA regulation has the authority to refuse such applications.
The FDA regulations:
- The FDA regulations which govern the disclosure of individual COIs include:
- Researchers must make an annual self-declaration of financial COIs to the FDA.
- The Applicants submitting marketing applications must disclose financial COIs of researchers who performed the clinical studies.
- It Concerns to disclose to the FDA’s financial COIs soon after submitting the IND application.
- It Sponsors for making an annual declaration of the financial COIs of researchers who did the clinical studies to the FDA.