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Center for Biologics Evaluation and Research: Difference between revisions
Center for Biologics Evaluation and Research (view source)
Revision as of 23:03, 9 January 2025
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==Scope== | ==Scope== | ||
* [[Blood]] for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and- [[Blood plasma|plasma]] derivatives, including [[intravenous immunoglobulin|immunoglobulins]], [[Hyperimmune globulin|hyperimmune]] products, and [[antitoxin]]s. | * [[Blood]] for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and- [[Blood plasma|plasma]] derivatives, including [[intravenous immunoglobulin|immunoglobulins]], [[Hyperimmune globulin|hyperimmune]] products, and [[antitoxin]]s. | ||
** Blood and blood products activities are managed through the Office of Blood Research and Review (OBRR)<ref>{{Cite web|url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm602922.htm|title=Director, Office of Blood Research and Review (OBRR)|last=<!-- no byline -->|date=28 March 2018|website=About the Center for Biologics Evaluation and Research|publisher=FDA|type=Job posting|access-date=28 March 2018}}{{self-published source|date=March 2018}}</ref> | |||
* Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels. | * Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels. | ||
* [[Vaccine]]s for use in humans. | * [[Vaccine]]s for use in humans. | ||