512 Understanding Expanded Access: Who are the Patients?
OBJECTIVES/GOALS: The FDA allows physicians to request clinical use of investigational drugs, biologics, and devices for patients with no satisfactory treatment options through a pathway called Expanded Access (EA). TEAMSS (Transforming Expanded Access to Maximize Support and Study) sought to examin...
Main Authors: | , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Cambridge University Press
2024-04-01
|
Series: | Journal of Clinical and Translational Science |
Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124004369/type/journal_article |