U.S. drug regulators have asked several pharmaceutical companies to repeat studies conducted at two Indian contract research organizations (CROs) (Synchron Research Services and Panexcell Clinical Lab) on data integrity concerns.
US Food and Drug Administration (USFDA) actions include tests at Ahmedabad-based Synchron and Navi Mumbai-based Panexcell facilities, and research data generated by these CROs and submitted in several applications.
Inspections and data analysis revealed serious cases of illegal activity and federal regulatory violations, resulting in invalid research data being submitted to the FDA, regulators said in a notice reviewed by the ET.
