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    
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.
Related Documents :
17213627 - Carbon felt-based bioelectrocatalytic flow detectors: highly sensitive amperometric det...
22889897 - A review of dietary and non-dietary exposure to bisphenol-a.
2764257 - A survey of indoor air quality in twenty-nine anchorage residences.
19139587 - Color sensors for indole vapors based on ehrlich-type reactions.
21875177 - Acoustic variability and individual distinctiveness in the vocal repertoire of red-capp...
16959477 - Postprandial responses in the african rhombig egg eater (dasypeltis scabra).
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    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Consuming the forest in an environment of crisis: nature tourism, forest conservation and neoliberal...
Next Document:  The impact of AVMA COE's accreditation on veterinary medical education.