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From the Food and Drug Administration
April 1, 1998

New Rules Require Financial Disclosure

Author Affiliations

Copyright 1998 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1998American Medical Association

JAMA. 1998;279(13):984. doi:10.1001/jama.279.13.984

The FDA has issued new rules that for the first time require sponsors of drug, device, or biologic marketing applications to disclose whether clinical investigators performing clinical studies on their products have financial interests that could affect the reliability of submissions for approval. The agency believes it is important to public health to ensure, as much as possible, that the safety and efficacy data submitted to the agency in support of marketing applications are free of the effects of any bias that may result from such financial interests. Public comments in response to the rule when first issued as a proposal indicate that potentially problematic financial arrangements occur only occasionally, although perhaps more often within small biotechnology and medical device firms.

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