Document Detail

Revisions to the general safety requirements for biological products; companion document to direct final rule--FDA. Proposed rule.
MedLine Citation:
PMID:  10178870     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by adding cellular therapy products to the list of products exempted from the general safety test (GST) and by adding an administrative procedure for obtaining exemptions from the GST requirements. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is taking this action because the GST may not be relevant or necessary for many types of biological products, including cellular therapy products, currently in various stages of development.
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Apr 
Date Detail:
Created Date:  1998-06-17     Completed Date:  1998-06-17     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  19431-4     Citation Subset:  H    
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MeSH Terms
Biological Products*
Device Approval / legislation & jurisprudence*,  standards
Equipment Safety
Guidelines as Topic
Policy Making
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Biological Products

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