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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