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 …

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