GUIDANCE DOCUMENT
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders February 2022
- Docket Number:
- FDA-2019-D-4247
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance (Guidance 2) is the second in a series of four methodological patient-focused drug development (PFDD) guidance documents that FDA is developing to describe in a stepwise manner how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.
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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2019-D-4247 .