""Biologics License Application"" — Epstein Files Search

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2 results for “"Biologics License Application"”

EFTA01092027Set 9

2013-10-125p2,524w

wounds. For certain expanded indications for Grafix, Osiris has committed to submit a Biologics License Application (BLA). o Osiris will leverage existing clinical data in the preparation of the applications ... considered a biological product subject to investigational new drug applications (INDs) and

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biologic

license

applications

(BLAs), and not a 361 HCT/P because the product is dependent upon the metabolic activity

https://www.justice.gov/epstein/files/DataSet%209/EFTA01092027.pdf

EFTA01092057Set 9

2013-08-165p2,594w

considered a biological product subject to investigational new drug applications (INDs) and biologic license applications (BLAs), and not a 361 HCT/P because the product is dependent upon the metabolic activity

https://www.justice.gov/epstein/files/DataSet%209/EFTA01092057.pdf

Corpus: 1990-03-17 – 2025-12-01

October 2013

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Results by Dataset2 total

Set 9

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