Pancreatic Islets Quality and Potency Cannot be Verified as Required for Drugs: Reflection on the FDA Review of a Biological License Application for Human Islets
Author
Witkowski, PiotrAnteby, Roi
Olaitan, Oyedolamu K
Forbes, Racheal C
Niederhaus, Silke
Ricordi, Camilo
Fair, Jeffrey H
Harland, Robert C
Date
2021-12Journal
TransplantationPublisher
Wolters Kluwer HealthType
Article
Metadata
Show full item recordKeyword
biologic license application (BLA)OPTN Final Rule
United States. Food and Drug Administration
Islets of Langerhans Transplantation--standards
Identifier to cite or link to this item
http://hdl.handle.net/10713/17361ae974a485f413a2113503eed53cd6c53
10.1097/TP.0000000000003880