Document Detail


Regulatory issues in the evaluation of antimetastatic and other novel anticancer therapies.
MedLine Citation:
PMID:  10357567     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This article outlines some of the complexities and challenges confronting researchers and the US Food and Drug Administration (FDA) in the area of evaluation of antimetastatic and other novel anticancer therapies. The scientific regulatory matrix utilized by the FDA is outlined. Subsequently, the complications encountered when designing and interpreting studies of antimetastatic drugs are described, and finally changes in the regulatory landscape both within the USA and internationally are considered.
Authors:
M A Friedman
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Cancer chemotherapy and pharmacology     Volume:  43 Suppl     ISSN:  0344-5704     ISO Abbreviation:  Cancer Chemother. Pharmacol.     Publication Date:  1999  
Date Detail:
Created Date:  1999-06-15     Completed Date:  1999-06-15     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  7806519     Medline TA:  Cancer Chemother Pharmacol     Country:  GERMANY    
Other Details:
Languages:  eng     Pagination:  S100-3     Citation Subset:  IM    
Affiliation:
US Food and Drug Administration, Rockville, MD 20857, USA.
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MeSH Terms
Descriptor/Qualifier:
Antineoplastic Agents / therapeutic use*
Drug Evaluation / legislation & jurisprudence*
Neoplasm Metastasis / drug therapy*,  prevention & control
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Antineoplastic Agents

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


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