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# Semler Research Studies ‘Unacceptable,’ FDA Says
- URL: https://www.fdaweb.com/semler-research-studies-unacceptable-fda-says/
- Published: 2016-04-21T12:00:00.000Z
- Updated: 2026-09-14T20:56:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135446

> FDA says that clinical and bioanalytical studies conducted for drug companies by Semler Research Private Limited, located in Bangalore, India, are not acceptable as a result of data integrity concerns and must be repeated. A [notice](http://www.fda.gov/Drugs/DrugSafety/ucm495778.htm?ref=fdaweb.com) to drug companies says that Semler is a contract research organization that conducts bioequivalence and bioavailability studies for a number of drug companies.  
>  
> The agency says that its 9/29-10/9/15 inspection at Semler found “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.” The company was issued a 4/19 [Untitled Letter](http://www.fda.gov/Drugs/DrugSafety/ucm496790.htm?ref=fdaweb.com) detailing the inspection findings.  
>  
> Evaluations of drugs that were approved based on data from Semler that support approval during the regulatory review process have not identified reports that raise serious safety concerns with the products, the notice says. But FDA is requiring that sponsors of approved applications repeat the bioequivalence/bioavailability studies using an entity other than Semler. The agency also is changing the therapeutic equivalence rating in the *Orange Book* for any approved ANDA that relied on Semler data to “BX,” meaning that data reviewed by the agency are insufficient to determine therapeutic equivalence.  
>  
> Letters from FDA are going to sponsors of applications that are currently under review that include data from studies conducted at Semler to inform them that they must repeat the bioequivalence/bioavailability studies using an entity other than Semler at an acceptable alternate study site.