FDA re­leas­es 81 prod­uct-spe­cif­ic guid­ances

The FDA on Thurs­day re­leased prod­uct-spe­cif­ic guid­ance doc­u­ments for 81 ac­tive phar­ma­ceu­ti­cal in­gre­di­ents to aid gener­ic drug de­vel­op­ment, in­clud­ing 28 new draft guid­ances and 53 re­vised draft guid­ances.

The guid­ances, when fi­nal­ized, are in­tend­ed to pro­mote gener­ic com­pe­ti­tion by clar­i­fy­ing the FDA’s ex­pec­ta­tions for the stud­ies re­quired to demon­strate that a gener­ic drug is equiv­a­lent to a ref­er­ence list­ed drug. So far, the FDA has is­sued near­ly 1,800 prod­uct-spe­cif­ic guid­ances.

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