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FINAL REPORTNASH ExternallyLedPatientFocused Drug Development (ELPFDD) Meeting NOVEMBER 4TH 20211CouncilCONTENTS 3 4BackgroundNonalcoholic Steatohepatitis (NASH) Overview6Meeting OverviewCollaborators
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What is externally led patient-focused drug?
Externally led patient-focused drug refers to a process or initiative where patients and external stakeholders lead the effort in drug development and regulation, ensuring that their needs and perspectives are prioritized.
Who is required to file externally led patient-focused drug?
Sponsors of drug development, including pharmaceutical companies and organizations engaging with patient communities, are typically required to file externally led patient-focused drug.
How to fill out externally led patient-focused drug?
To fill out the form for externally led patient-focused drug, sponsors must gather input from patients, summarize the patient experiences, and address the relevant regulatory requirements in the submission.
What is the purpose of externally led patient-focused drug?
The purpose of externally led patient-focused drug is to incorporate the voices of patients in the drug development process, ensuring that the resulting therapies address their real-world needs and concerns.
What information must be reported on externally led patient-focused drug?
Information that must be reported includes patient insights, experiences with the condition, data from surveys or focus groups, and how these insights influence drug development.
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