Article | August 27, 2021

505(b)(1) Versus 505(b)(2): They Are Not The Same

By Angela Drew, Ph.D., Product Ideation Consultant, Camargo, A Division of Premier Research

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The 505(b)(2) pathway can yield significant benefits in drug development cost and time. But what are the differences in 505(b)(1) versus 505(b)(2)? They are not the same.

Drug development pathways in the United States are referred to by their corresponding section in the Food, Drug, and Cosmetics Act: 505(b)(1), 505(b)(2), and 505(j). There are other pathways to approval for biologics (BLA) and medical devices (510k and PMA), but for this back-to-basics article we will compare the innovative small molecule pathways for approval, 505(b)(1) and 505(b)(2).

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