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- Title
Pediatric Drugs, Accelerated Approval, and Prospects for Reform.
- Authors
Ballreich, Jeromie; Kim, Hyung-Seok; Socal, Mariana
- Abstract
The article discusses the accelerated approval pathway used by the US Food and Drug Administration (FDA) to provide faster access to medicines. This pathway allows drugs to be approved based on surrogate endpoints, rather than traditional measures of efficacy. However, there are concerns about the lack of completion of confirmatory trials, which are required for full approval. The article highlights the need for reforms to the accelerated approval pathway, particularly in the context of pediatric drugs. It also mentions recent reforms enacted by Congress and the ongoing challenges in implementing the pathway effectively.
- Subjects
ACCELERATED life testing; DUCHENNE muscular dystrophy
- Publication
Pediatric Drugs, 2024, Vol 26, Issue 1, p5
- ISSN
1174-5878
- Publication type
Article
- DOI
10.1007/s40272-023-00597-4