FDA Premarket Pathways for Combination Products / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 355-360, 2022.
Artículo
en Chino
| WPRIM
| ID: wpr-939746
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.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Estados Unidos
/
United States Food and Drug Administration
/
Comercio
/
Seguridad de Productos para el Consumidor
/
Publicidad Directa al Consumidor
Tipo de estudio:
Guía de Práctica Clínica
País/Región como asunto:
America del Norte
Idioma:
Chino
Revista:
Chinese Journal of Medical Instrumentation
Año:
2022
Tipo del documento:
Artículo
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