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CRO Does Not Have Same Rights As Sponsor, Court Says In Tossing Semler Suit Against US FDA

 
• By Brenda Sandburg

Requiring re-do of Semler bioequivalence studies did not violate the CRO's due process rights, court finds; government has sovereign immunity from 'interference with economic advantage' claims.

Courthouse Inscription
Court finds the US FDA did not violate contract research organization's rights by requiring re-do of its bioequivalence studies.

A district court resoundingly rejected Semler Research Center Private Ltd.'s claims that the US Food and Drug Administration violated its rights and harmed its business by requiring a re-do of bioequivalence studies conducted for its pharmaceutical clients.

In a 17 September order, Judge Consuelo Marshall, of the US District Court for the Central District of California, granted the FDA's motion to dismiss Semler's second amended complaint. The suit stemmed from a 2015 inspection of Semler's bioavailability and bioequivalence (BA/BE) testing facility and corporate offices in Bangalore, India

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