Sorry should have included some of my key learnings:
These 2 points stood out for me:
- “The medicine has already been approved, that means FDA already has efficacy and safety data, maybe for a different disease, but still it is familiar with the product,” PhRMA’s Vereshchagina said of the STAR program.
- “NORD is pleased to see that FDA will consider the applicability of the endpoints for multiple diseases, which will help broaden the impact of the pilot beyond the selected applicants,” Ross said. “It is critical that the learnings from this program ultimately be made available so that future rare disease drug applications can build on the progress made within the program.”
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Sorry should have included some of my key learnings:These 2...
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