Remove 2011 Remove Labelling Remove Mayo Clinic
article thumbnail

NHC Submits Comments on FDA’s Draft Guidance for Voluntary Incorporation of Patient Preference Information

Putting Patients First Blog

Real-world case studies demonstrating how PPI has influenced decisions, such as targeted approvals or label modifications, would clarify its practical utility. 20 Specialized patient labeling should describe patient preferences for specific benefits and risks, tailored to the population most likely to use the device. 3 (2011): 3054.