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Changes at FDA may speed drug approval process and increase off-label use.

Authors :
Reh, Maggie
Reh, M
Source :
JNCI: Journal of the National Cancer Institute. 06/03/98, Vol. 90 Issue 11, p805-807. 3p. 2 Black and White Photographs.
Publication Year :
1998

Abstract

Presents information on the development of regulations by the United States Food and Drug Administration (FDA) in an attempt to improve the process of getting pharmaceuticals to market and expand potential uses of those already available. Information on the revisions required by the FDA Modernization Act of 1997 which was signed into law in November 1997; Requirements of the FDA to draft 42 regulations covering wide ranging areas of the agency's responsibilities.

Subjects

Subjects :
*DRUG marketing
*RULES

Details

Language :
English
ISSN :
00278874
Volume :
90
Issue :
11
Database :
Academic Search Index
Journal :
JNCI: Journal of the National Cancer Institute
Publication Type :
Academic Journal
Accession number :
731089
Full Text :
https://doi.org/10.1093/jnci/90.11.805