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Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020.
Overview
Identity
Additional Document Info
View All
Overview
authors
Johnston, James L
Dhruva, Sanket S
Joseph S. Ross, MD, MHS
Rathi, Vinay K
publication date
October 1, 2021
published in
JAMA internal medicine
Journal
has subject area
Device Approval
Humans
United States
United States Food and Drug Administration
Identity
Digital Object Identifier (DOI)
https://doi.org/10.1001/jamainternmed.2021.3042
PubMed ID
34152383
Additional Document Info
start page
1409
end page
1412
volume
181
issue
10