Has anyone explored CBER/biologics AAs?
I found a list of CDER + Biologic AAs
"Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint"
https://www.fda.gov/media/151146/download
as the pdf doesnt have a column distinguishing drugs from biologics, I guess I could work through it.
The rate of conversion looks good but I haven't analysed.
I was interested in researching track record of AAs for biologics under CBER and thus determining implications for BLA AA path for Revascor in HLHS and then of course weighting of Wonka's magic ticket vis a vis designation.
Ann: FDA Grants Rare Pediatric Disease Designation for Revascor, page-225
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