Consider 505(b)(2) Pathway [Design Issues]

posted by bebac_fan – US, 2018-05-05 17:08 (935 d 01:45 ago) – Posting: # 18756
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I think this would need to go through a NDA/505(b)(2) pathway rather than an ANDA.

In this case, comparative efficacy, rather than BE, will be considered pivotal.

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