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RegisterConsider 505(b)(2) Pathway [Design Issues]
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.
In this case, comparative efficacy, rather than BE, will be considered pivotal.
Complete thread:
- Bioequivalence of IR vs MR tablet heritage 2018-05-05 06:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Consider 505(b)(2) Pathwaybebac_fan 2018-05-05 17:08
- Pathway for Softgel vs Tablet Comparison Obinoscopy 2018-05-15 19:04
- Pathway for Softgel vs Tablet Comparison jag009 2018-05-18 16:33
- Pathway for Softgel vs Tablet Comparison Obinoscopy 2018-05-15 19:04
- Consider 505(b)(2) Pathwaybebac_fan 2018-05-05 17:08
Ing. Helmut Schütz