Document Detail


International Conference on Harmonisation; addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; availability. Notice.
MedLine Citation:
PMID:  22616137     Owner:  HSR     Status:  In-Process    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals'' (S6 addendum). The S6 addendum was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The S6 addendum is intended to incorporate new knowledge and experience gained since the implementation of the ICH guidance entitled ``S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals'' (ICH S6) and to clarify and provide greater detail to enable the development of safe and effective biopharmaceuticals.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  77     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-05-22     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  29665-6     Citation Subset:  T    
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