Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
Regulatory considerations when developing biological products. Report of the Center for Biologics Evaluation and Research
Summary
The Center for Biologics Evaluation and Research, whose regulatory authority includes monoclonal antibodies, cytokines, vaccines, toxins and somatic cellular therapies, communicates to sponsors issues for consideration in the development of biological products through the publication of "Points to Consider" and "Guideline" documents. This paper summarizes the available "Points to Consider" and "Guideline" documents and outlines recommendations from these documents for characterizing the cells used to produce biological products.
Prognia summarises this guideline for reference and education. It is not medical advice. Always check the official guideline and current local protocols before acting on it.
Study materials
At a glance
- Organisation
- Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
- Published
- 1992
- Region
- United States
- Language
- English
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