The Food and Drug Administration has issued a proposed rule to require sponsors of clinical trials to report within 45 days any known information that a person has, or may have, falsified data in the course of a regulated study involving human or animal subjects.

"This proposal is necessary because ambiguity in the current reporting scheme has caused confusion among sponsors," the agency noted in the rule, published Feb. 19 in the Federal Register. "The proposed rule is intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims, and to protect research subjects."

Under the proposed rule, reporting to the FDA would be required if falsification of data is known or suspected in the course of reporting study results, or while proposing, designing, performing, recording, supervising or reviewing studies.

The FDA will accept public comment through May 20. The proposed rule is available at

--Joseph Goedert

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