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STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues
Citing "objectionable conditions," the agency said there were problems with the way Raptim Research tested medicines in India.
In a rare move, the Food and Drug Administration told an unspecified number of generic companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by a contract research organization.
The agency identified “significant” problems with data integrity and the way studies were conducted by Raptim Research, which had been hired by the drugmakers to test their medicines. The FDA expressed concern, specifically, about in-vitro studies, which are run to test biological processes.
During an April 2023 inspection at Raptim facilites in Nava Mumbai, India, FDA inspectors found “objectionable conditions” that led them to conclude the company falsified data in testing for multiple subjects and samples across multiple studies, according to a letter sent last week to the pharmaceutical companies.
