Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, a Harmonization by Doing Proof-of-Concept: The Japanese and US Regulatory Perspective.
Coronary artery calcification
Coronary artery disease
Global clinical trial
Global medical device development
Harmonization by Doing
Orbital atherectomy
Percutaneous coronary intervention
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
04 2022
04 2022
Historique:
received:
23
08
2021
accepted:
23
08
2021
pubmed:
7
9
2021
medline:
13
4
2022
entrez:
6
9
2021
Statut:
ppublish
Résumé
Regulatory approval processes for medical devices in Japan and the United States of America (US) often require similar clinical trials to establish safety and effectiveness. The Harmonization by Doing (HBD) program provides a collaborative environment for communication between regulators, academics and industry, facilitating the design and conduct of US/Japanese clinical trials supporting approval in both countries.
Identifiants
pubmed: 34483075
pii: S1553-8389(21)00623-0
doi: 10.1016/j.carrev.2021.08.020
pii:
doi:
Types de publication
Letter
Comment
Langues
eng
Sous-ensembles de citation
IM
Pagination
118-119Commentaires et corrections
Type : CommentOn
Informations de copyright
Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Declaration of competing interest Authors are employees of government regulatory agencies and have no declarations of interest.