Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

PubMed

US regulatory compliance for medical combination products: an overview.

PMID: 39736921 ·

M, a, n, a, v, , V, , S, i, n, g, h, ;, , P, r, a, f, u, l, l, a, , A, p, s, h, i, n, g, e, k, a, r, ;, , S, a, n, y, a, m, , G, a, n, d, h, i, ;, , O, m, , V, , S, i, n, g, h

RevistaFrontiers in medical technology
Ano
PMID39736921

Resumo

This article provides a high-level overview of US regulatory review and approval processes for the growing field of medical combination products (CPs; those merging drugs with devices and/or biological products). US law defines drugs, medical devices, and CPs in specific ways, and the components of a CP are still subject to their respective regulations while combined. The Food and Drug Administration's Office of Combination Products (OCP) oversees the review and classification of CPs, which is b

Fonte oficial

Ver no PubMed →

Dados provenientes do PubMed / NCBI. Para consultar o texto integral e as informações mais recentes, recorra sempre ao registo oficial.

↑