Impact of changes in regulatory framework on approval of medicines for rare diseases and applicability to market access policies
The introduction of the Orphan Drug Act in the USA in 1983, followed by adoption of the Orphan Drug Regulation No 141/2000 in the EU in 2000, led to a change in landscape of drug development for rare diseases. The introduction of regulations, guidance documents and incentives aimed at increasing the...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-04-01
|
| Series: | Frontiers in Medicine |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2025.1474087/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|