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ResourcesResearch IntegrityAs China cracks down on faked drug trial data, US FDA abandons disclosure rule – Retraction Watch (Adam Marcus | October 2018)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

As China cracks down on faked drug trial data, US FDA abandons disclosure rule – Retraction Watch (Adam Marcus | October 2018)

 


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The FDA has walked away from a 2010 rule that would have forced drug makers to disclose fabricated data to regulators.

As Bloomberg Law reported last week, the FDA has withdrawn the proposed rule, “Reporting Information Regarding Falsification of Data,” which would

require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. This proposal is necessary because ambiguity in the current reporting scheme has caused confusion among sponsors. 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.

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