Last April, the Food and Drug Administration alerted an untold number of drug makers that marketing applications containing clinical trial data prepared by Semler Research Center, an Indian contract research organization, would not be accepted due to concerns about the integrity of the data.

Now, the company has filed a lawsuit seeking $50 million in damages and accusing the agency of a lack of due process, exposure to claims from customers totaling about $20 million, and the loss of a potential sale that could have yielded $30 million. In short, Stemler alleges the FDA caused a “stigma (that) led to the complete annihilation” of its business.

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