FDA+ roundup: New draft guid­ance on ther­a­peu­tic equiv­a­lence; Cavaz­zoni talks ac­cel­er­at­ed ap­provals

The FDA on Wednes­day re­leased new draft guid­ance spelling out ex­act­ly how it con­ducts ther­a­peu­tic equiv­a­lence (TE) eval­u­a­tions for gener­ic and fol­low-on drugs.

The 14-page draft, which ends with 14 fre­quent­ly asked ques­tions re­lat­ed to TE, ini­tial­ly ex­plains how the sci­en­tif­ic and reg­u­la­to­ry foun­da­tion for the eval­u­a­tion of TE in­volves three main com­po­nents: Phar­ma­ceu­ti­cal equiv­a­lence, bioe­quiv­a­lence, and es­tab­lish­ing the same clin­i­cal ef­fect and safe­ty pro­file for the con­di­tions of use as spec­i­fied in the la­bel.

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