FDA calls for repeat bioequivalence studies after uncovering 'invalid' data from two Indian CROs
After finding “significant instances of misconduct and violations of federal regulations,” leading two Indian CROs to submit “invalid study data to FDA,” the agency is now calling on certain unnamed generic and brand name drug companies to run bioequivalence tests again for some of their marketed products.
The FDA said that after looking into the clinical and bioanalytical studies conducted by Synchron Research Services in Gujarat, India, and Panexcell Clinical Lab in Maharashtra, India following an inspection in late Nov. 2019, data from either company are no longer acceptable to support a determination of safety or effectiveness for brand name drugs, or to show affected generic drugs are bioequivalent to their brand name counterparts.
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