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- Expanded Access (Compassionate Use) Submission Data | FDA
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) expanded access submission receipt reports for INDs and Protocols from 2019-2023
- An approach to data collection in compassionate use managed access
Therefore, a robust in-country CU regulatory framework should provide clarity on the collection of patient outcome data for evaluation and the type of data which can be collected, in line with the applicable local data protection or privacy regulations
- The Global Guide to Compassionate Use Programs
Compassionate Use and Expanded Access programs, a comprehensive guide to complex country regulations, formal guidance documents, submission requirements, applications and clarifying the roles and responsibilities of key parties
- Expanded Access Programs: Regulatory Strategy for Compassionate Use - DLRC
Expanded Access Programs (EAPs), also called Compassionate Use Programs (CUPs) have potential for allowing patient treatment using unlicenced medicines, separate from clinical trials and prior to marketing authorisation in the patient’s country, when no other treatment option is available
- Compassionate Use Program Strategy - umbrex. com
Data collected from compassionate use patients will not be used to support regulatory submissions, but it will contribute to post-market safety surveillance once the drug is approved
- An approach to data collection in compassionate use managed access
In the absence of a harmonized framework on CU data collection, Novartis developed a company-wide guidance to collect baseline patient data and prospective follow-up information at product resupply
- Expanded Access | FDA
Learn about expanded access, including information about the expanded access process, what FDA considers, and what costs may be involved Learn about expanded access, including information about
- Applying real-world data from expanded-access (“compassionate use . . .
Using real-world evidence derived from clinical treatment has the potential to create a new way of incorporating data that could inform manufacturers and regulatory authorities on important approaches, potentially accelerate drug development, and at the very least, make it more patient-centered
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