FDA to Develop Patient-Focused Drug Development Guidance

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FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.

On Sept. 3, 2019, FDA announced that it will be developing a series of guidance documents as part of the agency’s patient-focused drug development efforts in accordance with the 21st Century Cures Act and The Food and Drug Administration Reauthorization Act of 2017 Title I.

There will be four guidance documents on methodological patient-focused drug development in the series, and they will address how stakeholders can collect and submit patient data and other relevant patient information for the development of medical products.

The first guidance, Collecting Comprehensive and Representative Input, will discuss sampling methods used when planning to collect patient input. Guidance number two, Methods to Identify What is Important to Patients, will discuss methods for eliciting information from patients identified in guidance one and gathering information on symptoms and impact on patients. The third guidance will address refining the list of important impacts and concepts to develop study instruments, and the fourth guidance will address methodologies, standards, and technologies for the collection, capture, storage, and analysis of clinical outcome assessment data.


“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 said in the announcement.

Source: FDA