April 1998 Bulletin

FDA to seek investigator’s financial ties

The Food and Drug Administration has published regulations requiring any application for FDA approval to market a drug, device or biological product include information about the financial interests of investigators who conducted clinical studies to support the application.

If an applicant does not certify that the clinical investigators have no interest in the drug, device or product; disclose the nature of the interest; or certify that the information cannot be obtained, the FDA may refuse the application. FDA does not intend to ban the financial arrangements because it "recognizes that therapeutically beneficial products have been developed through clinical investigations that were conducted by the product patent holder, or for which clinical investigators were compensated with equity in the sponsor’s firm. FDA will give studies done by investigators with a financial interest "close scrutiny and evaluation." The final rule will be effective Feb. 2, 1999.

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