FDA Advisory Meeting on Capricor’s Deramiocel BLA
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FDA is opening a public comment docket and scheduling an advisory committee meeting on Capricor’s biologics license application for deramiocel, a cell therapy product. The meeting will be public and held online on July 29, 2026. Biotech companies, healthcare professionals, patient groups, investors, and other stakeholders can submit comments before the docket closes on July 28, 2026. Comments submitted by July 20 will be shared with the advisory committee before the meeting.
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Key Changes
- FDA schedules a public advisory committee meeting for July 29, 2026
- FDA opens docket FDA-2026-N-6771 for public comments on the deramiocel BLA
- Comments are due by July 28, 2026, with July 20 as the deadline for comments to be provided to the committee before the meeting
Obligations
What this law requires
Stakeholders who want FDA to consider comments on docket FDA-2026-N-6771 must submit electronic comments through Regulations.gov by 11:59 p.m. Eastern Time on July 28, 2026; late comments will not be considered.
Stakeholders submitting written or paper comments by mail, hand delivery, or courier must ensure FDA receives them on or before July 28, 2026, for the comments to be considered timely.
Stakeholders who want their comments provided to the Cellular, Tissue, and Gene Therapies Advisory Committee before the meeting must submit comments on or before July 20, 2026.