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The FDA's regulation governing disclosure of individual COIs requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or to disclose financial interests of researchers who conducted clinical studies covered by the regulation. The regulation specifies that the FDA may refuse to file any marketing application that does not contain a disclosure of researchers' financial interests or a certification that the applicant acted with due diligence to obtain researchers' disclosures, but was unable to do so. What is required of applicants submitting marketing applications for drugs, biologics, or devices according to the FDA's regulation?
a. Certification of financial interests
b. Disclosure of certain financial interests
c. Certification of non-financial interests
d. No disclosure or certification required