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Extending the US Food and Drug Administration's Postmarket Authorities
Holly Fernandez Lynch
, Rachel E. Sachs
, Sejin Lee
, Matthew Herder
, Joseph S. Ross
, Reshma Ramachandran
Institute of Clinical and Translational Sciences (ICTS)
Research output
:
Contribution to journal
›
Article
›
peer-review
20
Scopus citations
Overview
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Keyphrases
U.S. Food
100%
Postmarket
100%
Accelerated Approval
57%
Efficacy Study
42%
Regulatory Flexibility
42%
Drug Approval
28%
Post-marketing Study
28%
Residual Uncertainty
28%
New Drugs
14%
Politicians
14%
Extended Period
14%
Payers
14%
Pivotal Trial
14%
Statute
14%
Legislative Reform
14%
Existing Problems
14%
Federal Food
14%
Legal Authority
14%
Market Access
14%
Early Markets
14%
Pharmacology, Toxicology and Pharmaceutical Science
Efficacy Study
100%
Drug Approval
66%
Cosmetics
33%
Agricultural and Biological Sciences
Federal Food, Drug and Cosmetics Act
100%
Economics, Econometrics and Finance
Market Access
100%