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Patient Experience Data: US FDA Guidance Offers Other Ways To Share

 
• By Brenda Sandburg

Beyond submitting proposed guidances to FDA, stakeholders may develop patient registries, conduct natural history studies, and establish partnerships to help advance patient-focused drug development, agency suggests.

Patient 3D sphere Word Cloud Concept with great terms such as medicine, rights, healthcare and more. - Illustration

The US FDA adopted the advice of patient advocates in developing draft guidance on how to submit proposed guidances relating to patient experience data. The document lists other ways that external groups can help advance patient-focused drug development, such as by developing a patient registry, conducting natural history studies or collaborating with sponsors.

The draft guidance, Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data, describes the factors stakeholders should consider when planning and determining whether to develop a proposed...

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