Hi NZT,
The below study may give us an indication of which variant regulatory pathway on the Orphan Drug FDA status we may take for a repurposed drug ( Monepantel).
Utilizing 505(b)(2) Regulatory Pathway for New Drug Applications: An Overview on the Advanced Formulation Approach and Challenges. Jiayi Chen et al 2023
Kpax
Hi NZT,The below study may give us an indication of which...
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