Final draft pro voices series#

Hypothetical Case Examples: Provide practical supplemental information to illustrate important concepts present in FDA’s draft guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.Patient-Focused Drug Development Glossary: Standardized nomenclature and terminologies related to patient-focused medical product development.Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. Final Guidance: Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.It also provides a general overview of the relationship between potential research question(s) and method(s) when deciding from whom to get input (including defining the target population and development of the sampling strategy). Guidance 1 discusses sampling methods that could be used when planning to collect patient input. For an outline of FDA’s planned timeframe for development of the guidance, please refer to the Plan for Issuance of Patient-Focused Drug Development Guidance. This webpage contains information and documents related to FDA’s development of the methodological PFDD guidances, including public workshops, draft guidances, and hypothetical scenarios, which are all intended to serve as a basis for dialogue. These guidances are part of FDA’s PFDD efforts in accordance with the 21st Century Cures Act and The Food and Drug Administration Reauthorization Act of 2017 Title I.

Final draft pro voices series#

This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making.

FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making.