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Las prácticas de transparencia en la FDA: una barrera para la salud mundial
Murray M Lumpkin1, Margaret A Hamburg2, William B Schultz3
1Bill & Melinda Gates Foundation, Seattle, WA, USA.
Science (New York, N.Y.)
|August 4, 2022
Resumen
El intercambio de datos reglamentarios debe convertirse en una práctica habitual. Esto garantiza una colaboración eficiente y una toma de decisiones oportuna en los procesos regulatorios, lo que lo convierte en una rutina en lugar de una excepción.
Área de la Ciencia:
- Ciencias de la regulación
- Gestión de la información
Sus antecedentes:
- Las prácticas actuales de intercambio de datos entre los organismos reguladores a menudo son inconsistentes.
- El establecimiento de un intercambio rutinario de datos es crucial para la supervisión regulatoria moderna.
Objetivo del estudio:
- Abogar por la normalización del intercambio de datos entre las agencias reguladoras.
- Destacar las ventajas del intercambio integrado de datos para las funciones reguladoras.
Principales métodos:
- Análisis de los protocolos de intercambio de datos reglamentarios vigentes.
- Revisión de las mejores prácticas en el intercambio de información entre agencias.
Principales resultados:
- El intercambio de datos es esencial para las operaciones regulatorias eficientes.
- Tratar el intercambio de datos como algo normal simplifica los procesos.
Conclusiones:
- El intercambio de datos reglamentarios debe estandarizarse.
- La aplicación del intercambio rutinario de datos mejora la eficacia y el cumplimiento normativos.
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