US industry concerned about FDA's data falsification rule

 
• By Vibha Sharma

The US pharmaceutical and clinical research industry has expressed serious concerns about a new rule proposed by the Food and Drug Administration, which, if finalised, would require sponsors to report to the agency about any individual who has, or may have, engaged in falsification of data in studies involving human or animal subjects1,2.

The US pharmaceutical and clinical research industry has expressed serious concerns about a new rule proposed by the Food and Drug Administration, which, if finalised, would require sponsors to report to the agency about any individual who has, or may have, engaged in falsification of data in studies involving human or animal subjects1,2.

As sponsors could face criminal sanctions (including fines and imprisonment) for failure to submit such reports no later than 45...

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