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.

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