FDA of­fers new guid­ance to help gener­ic drug de­vel­op­ers get to mar­ket more quick­ly

The FDA on Wednes­day re­leased a trio of new guid­ance doc­u­ments un­der its Drug Com­pe­ti­tion Ac­tion plan to help the gener­ic drug in­dus­try with a more ef­fi­cient and trans­par­ent gener­ic drug re­view process.

One of the two fi­nal guid­ances re­leased deals with how the agency is­sues and us­es in­for­ma­tion re­quests (IRs) and dis­ci­pline re­view let­ters (DRLs) dur­ing the as­sess­ment of an orig­i­nal gener­ic drug ap­pli­ca­tion, al­so known as an ab­bre­vi­at­ed new drug ap­pli­ca­tion or AN­DA.

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