Cargando...

Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways

Developing a novel drug, including discovery, nonclinical toxicology studies, initial clinical trials, and thorough pivotal studies, may take many years. Once an applicant has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the mar...

Descripción completa

Guardado en:
Detalles Bibliográficos
Publicado en:Clin Transl Sci
Autores principales: Cox, Erica M., Edmund, Anita V., Kratz, Erica, Lockwood, Sarah H., Shankar, Aishwarya
Formato: Artigo
Lenguaje:Inglês
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC7214660/
https://ncbi.nlm.nih.gov/pubmed/31909876
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12745
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!