The US FDA has objected to studies conducted by India-based contract research organizations Panexcell Clinical Lab and Synchron Research Services, because of data integrity concerns. The FDA has warned pharmaceutical companies sponsoring drug application approvals, that data generated by Panexcell and Synchron will be “unacceptable.”
Abbreviated new drug application sponsors will have to find alternative third parties to conduct their repeat clinical and bioanalytical studies after the US Food and Drug Association found that data generated by those from Panexcell Clinical Lab and Synchron Research were “unacceptable.”
The association has warned pharmaceutical companies applying for new drug applications and abbreviated new drug applications against using data generated...
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