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USFDA Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle
The guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle was issued on 30 March 2026 , updating and superseding the earlier 2016 guidance, and providing comprehensive recommendations on how patient preferences can inform benefit-risk assessments. The FDA recognizes that patients living with diseases or conditions develop first-hand insights into treatment benefits and risks. Their perspectives can play a critical role in evaluatin
Sharan Murugan
16 hours ago2 min read
USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
USFDA's Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) released a draft...
Sharan Murugan
Sep 6, 20242 min read