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Experiences With and Challenges Afforded by Expedited Regulatory Pathways.

Authors :
Liu, Sheng
Kesselheim, Aaron S.
Source :
Clinical Pharmacology & Therapeutics; Apr2019, Vol. 105 Issue 4, p795-797, 3p
Publication Year :
2019

Abstract

The article discusses the required evidence submitted by the pharmaceutical manufacturer to the U.S. Food & Drug Administration for approval. Topics mention including the accelerated approval formalized by the U.S. Congress in 1992, confirming the drug effectivity and application of surrogate measure.

Subjects

Subjects :
DRUG approval
DRUG development
PHARMACEUTICAL industry
DRUG efficacy

Details

Language :
English
ISSN :
00099236
Volume :
105
Issue :
4
Database :
Complementary Index
Journal :
Clinical Pharmacology & Therapeutics
Publication Type :
Academic Journal
Accession number :
135400672
Full Text :
https://doi.org/10.1002/cpt.1365
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