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Expanded Access Requests – RWD Collection Records (Communications, Protocols, Sponsor Reports)
Expanded Access Requests – RWD Collection Records (Communications, Protocols, Sponsor Reports)
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$89.00 USD
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Request Contents: Records of all approved Expanded Access requests involving real-world data (RWD) collection, including (as of 2024):
Related communications
Protocols
Sponsor reports
Whether the collected real-world evidence (RWE) is intended for use in a supplemental or original NDA/BLA
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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