The FDA has ordered Raptim Research, a clinical research company based in India, to redo several studies after the agency found evidence of data falsification.
The FDA’s investigation, which was initiated in April 2023, found the company had manipulated study data in a way that could mislead the approval process for generic drugs, according to a March 27 letter from the agency.
In the investigation, the FDA found suspiciously similar results in multiple studies involving skin samples, which they concluded was statistically unlikely. This raised concerns that the company had reused data from the same skin donor and reused it across different trials.
Despite Raptim explaining the discrepancies to the FDA, the agency concluded the data submitted to support drug applications was not trustworthy and is requiring the company to repeat the affected studies.
