FDA re­vis­es guid­ance on post­mar­ket­ing stud­ies to re­flect ARIA sys­tem, SUP­PORT act

The FDA on Thurs­day re­vised its draft guid­ance on post­mar­ket­ing stud­ies and clin­i­cal tri­als un­der Sec­tion 505(o)(3) of the Fed­er­al Food, Drug, and Cos­met­ic Act (FD&C Act).

The FDA says the draft guid­ance, first is­sued for com­ment in 2011, is be­ing re­vised to de­tail the fac­tors the agency con­sid­ers when de­ter­min­ing whether a post­mar­ket­ing study or clin­i­cal tri­al will be re­quired for a drug or bi­o­log­ic or whether post­mar­ket­ing re­ports and the agency’s ac­tive post­mar­ket risk iden­ti­fi­ca­tion and analy­sis (ARIA) sys­tem are suf­fi­cient to as­sess a prod­uct’s risks in the post­mar­ket set­ting.

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