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FDA
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FDA-2025-P-1355
Requests the Commissioner cancel the ADCOM panel and move to expedite approval for cardiosphere cell therapy (also know as deromiocel or Cap-1002) given the successful statistically significant achievement of primary endpoints that were accepted and vetted by FDA throughout clinical development and during Regenerative Therapy Advanced Treatment (RMAT) discussions
Documents
4
Comments
0
Description
Open
Key Dates
Comment Period OpensMay 21, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CBER
Citizen Petition
Requests the Commissioner cancel the ADCOM panel
and move to expedite approval for cardiosphere
cell therapy (also know as deromiocel or
Cap-1002) given the successful statistically
significant achievement of primary endpoints
that were accepted and vetted by FDA
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