NDA

Difference Between (NDA) 505(b)(1) and  (NDA) 505(b)(2)
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Difference Between (NDA) 505(b)(1) and (NDA) 505(b)(2)

Ever wondered about the difference between a completely new drug (NDA) 505(b)(1)and a hybrid drug (NDA)505(b)(2)? Let’s explore the contrast between these two pathways!   A 505(b)(2) New Drug Application (NDA) is a regulatory pathway in the United States that allows for the submission and approval of certain new drug products. The name “505(b)(2)” comes…