In a rare move, the U.S. Food and Drug Administration has notified an untold number of drug makers that some of their clinical trials must be repeated due to serious data problems at a pair of companies in India that run studies for the pharmaceutical industry.
The action stems from inspections at two contract research organizations — Synchron Research Services and Panexcell Clinical Lab — that were conducted in 2019. After running its own analyses, the agency found “significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA,” according to a Sept. 16 statement posted by the FDA.
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