Medicinal products meet medical devices: Classification and nomenclature issues arising from their combined use.
Drug Discov Today
; 27(10): 103324, 2022 10.
Article
em En
| MEDLINE
| ID: mdl-35872298
ABSTRACT
When a medicinal product (MP) and a medical device (MD) are combined, their correct classification implies discrimination among different possible scenarios, based on the nature of the combination and the principal mechanism of action. In the European Union (EU), stakeholders deal with a lack of harmonization, which can represent an obstacle toward the development of these products, and a complex nomenclature, emerging from two divergent regulatory philosophies (i.e., that of MPs and that of MDs). In the USA, where the US Food and Drug Administration (FDA) supervises MDs, drugs, and biological products, stakeholders interact with a single authority, where any issue is addressed internally.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Produtos Biológicos
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Drug Discov Today
Assunto da revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Itália