FDA Issues Draft Guidance: Patient-Focused Drug Development: Collecting Comprehensive and Representative Input- Drug Information Update

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Today the U.S. Food and Drug Administration issued Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. This draft guidance is the first in a series, as a collection these guidances are designed to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better and more consistently inform medical product development and regulatory decision making. This draft guidance specifically addresses questions such as “Whom do you get input from, and why? How do you collect the information?” It discusses sampling methods that could be used when planning to collect patient input. It also provides a general overview of how the relationship between potential research question(s) and method(s) need to be considered when deciding from whom to get input (including defining the target population and development of the sampling strategy). This draft guidance also includes a glossary of terms that will be used in this and one or more future guidances. The science of patient input is constantly evolving, and gathering robust and meaningful patient experience data to inform medical product development is a collaborative process. The PFDD meetings conducted to date have given FDA a deeper appreciation for the expertise that patients and caregivers can bring to the process and the value of incorporating their perspectives. Please see the Commissioner’s Statement  for more information.  Interested parties are encouraged to submit comments on this draft guidance. Comments will be accepted through the Federal Register system.