The FDA recently issued a notice to pharma companies that drug applications with data from two clinical research organizations will no longer be acceptable.
According to the agency, NDAs and ANDAs from Synchron Research Services and Panexcell Clinical Lab — both located in India — are not considered acceptable due to data integrity concerns. Any studies using clinical and bioanalytical data from the CROs will have to be repeated.
The agency said that it decided to take action after its own analysis of study data from the CROs found “significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA.”
The denial of data from the CROs will impact both safety and efficacy data for branded drugs and bioequivalence studies of generic products.
The agency also issued an “untitled letter” to each company detailing the specific violations found during facility inspections conducted in 2019. Information about which studies and drug sponsors are being impacted by the new ban on data from the CROs was redacted from the letters.
