FDA re­leas­es flur­ry of new, re­vised drug-spe­cif­ic guid­ance doc­u­ments

In an ef­fort to pro­vide sup­port for ab­bre­vi­at­ed new drug ap­pli­ca­tions, the FDA on Thurs­day is­sued a flur­ry of prod­uct-spe­cif­ic rec­om­men­da­tions, pro­vid­ing guid­ance for com­pa­nies look­ing to de­vel­op gener­ic ver­sions of a num­ber of pop­u­lar med­i­cines, in­clud­ing My­lan’s EpiPen (ep­i­neph­rine) al­ter­na­tive Adrenaclick, No­var­tis’ can­cer treat­ment Afin­i­tor (everolimus) and As­traZeneca’s can­cer treat­ment Lyn­parza (ola­parib).

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