Home » How Will the FDA Use Data Collected From Sponsors?
How Will the FDA Use Data Collected From Sponsors?
November 4, 2010
With its proposed rule concerning the falsification of data, the FDA intends to use information collected from study sponsors to identify patterns, potential signals or other indications of misconduct to form the basis of further investigations. The rule would address the agency’s concern that “an investigator who may have falsified data might continue to conduct studies.” Sponsors would be required to report information suggesting an investigator has or may have falsified data related to studies conducted by the sponsors or on their behalf.