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Food and drug administration expanded access to treatment
Author(s) -
Freedman Ralph S.,
Markman Maurie
Publication year - 2007
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.22681
Subject(s) - food and drug administration , medicine , investigational drugs , expanded access , drug approval , drug , administration (probate law) , investigational device exemption , drug administration , pharmacology , clinical trial , oncology , law , political science
On December 14, 2006, the FDA published simultaneously in the Federal Register their proposed rules amending regulations for expanded access to investigational drugs and for charging patients for investigational drugs. These proposed rules, if approved, could have important implications for patients, providers, and for Pharma.