US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development.
Drug Discov Today
; 28(7): 103618, 2023 07.
Article
en En
| MEDLINE
| ID: mdl-37196760
ABSTRACT
The 505(b)(2) NDA pathway can reduce drug development costs and accelerate the time to market by leveraging existing public data using clinical bridging and regulatory strategies. Whether or not a drug qualifies for the 505(b)(2) pathway depends on the active ingredient, drug formulation, clinical indication and other factors. Clinical programs can be streamlined and accelerated, and confer unique marketing benefits, such as exclusivity, depending on the regulatory strategy and product. Considerations for chemistry, manufacturing and controls (CMC) and the unique manufacturing issues that can arise owing to the accelerated development of 505(b)(2) drug products are also discussed.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Desarrollo de Medicamentos
Tipo de estudio:
Prognostic_studies
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Drug Discov Today
Asunto de la revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2023
Tipo del documento:
Article