Communicating With the FDA: The "Third Rail" of a New Model for Drug Development

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Bibliographic Details
Published in:	Journal of clinical pharmacology Vol. 48; no. 2; pp. 144 - 145
Main Authors:	Stanski, Donald R., Orloff, John J.
Format:	Journal Article
Language:	English
Published:	Oxford, UK Blackwell Publishing Ltd 01-02-2008 SAGE Publications Sage Publications, Inc
Subjects:	biomarkers Clinical Trials as Topic - methods Clinical Trials as Topic - standards communication Drug Approval - legislation & jurisprudence Drug Approval - methods Drug Approval - statistics & numerical data Drug development Drugs FDA Government Regulation Guidelines as Topic Humans Interdisciplinary Communication Investigational New Drug Application - legislation & jurisprudence Investigational New Drug Application - methods Investigational New Drug Application - statistics & numerical data Laws, regulations and rules Legislation, Drug - standards modeling and simulation United States United States Food and Drug Administration - legislation & jurisprudence United States Food and Drug Administration - organization & administration United States Food and Drug Administration - standards United States
Online Access:	Get full text
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Bibliography:	istex:DB010470C27DF591CD7AA0E94AFDC9AA6A26BDC2 ark:/67375/WNG-TSVWTVGP-J ArticleID:JCPH549 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Article-2 ObjectType-Feature-3 ObjectType-Commentary-1
ISSN:	0091-2700 1552-4604
DOI:	10.1177/0091270007313560