EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age

As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The parallel scientific advice program shared by the European Medicines Agency (EMA) and the...

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Detalles Bibliográficos
Autores principales: Thor, Shannon, Vetter, Thorsten, Marcal, Anabela, Kweder, Sandra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9985489/
https://www.ncbi.nlm.nih.gov/pubmed/36871110
http://dx.doi.org/10.1007/s43441-023-00501-9
Descripción
Sumario:As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The parallel scientific advice program shared by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) provides a mechanism for experts to concurrently engage in scientific discourse with sponsors on key issues during the development phase of new medicinal products (drugs, biologicals, vaccines, and advanced therapies).

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