FDA Premarket Pathways for Combination Products / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 355-360, 2022.
Article
de Zh
| WPRIM
| ID: wpr-939746
Bibliothèque responsable:
WPRO
ABSTRACT
Combination products face unique R&D, manufacturing, clinical, and regulatory challenges compared to individual devices, drugs, or biological products. Based on the interpretation of the relevant policies and the latest principles of combination products, this paper expounds the FDA's guidance, application trends, and application strategies for the pre-market pathways of combination products, with a view to providing relevant information for Chinese researchers and manufacturers when they start to entry the United States market.
Mots clés
Texte intégral:
1
Indice:
WPRIM
Sujet Principal:
États-Unis
/
Food and Drug Administration (USA)
/
Commerce
/
Sécurité des produits de consommation
/
Publicité s'adressant directement au consommateur
Type d'étude:
Guideline
Pays comme sujet:
America do norte
langue:
Zh
Texte intégral:
Chinese Journal of Medical Instrumentation
Année:
2022
Type:
Article