viernes, 3 de mayo de 2019

FDA In Brief: FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices



FDA In Brief: FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices 

The U.S. Food and Drug Administration today opened a docket to receive input from stakeholders on a new priority list of patient preference-sensitive areas that may impact the design and conduct of premarket medical device clinical studies, benefit-risk assessments and postmarket evaluation. The priority list, developed based on public input the agency previously received, is intended to provide greater clarity about areas in which the FDA would find patient preference information most informative for medical device regulatory decisions

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-advances-science-patient-input-seeking-specific-feedback-patient-preferences-may?utm_campaign=050219_FIB_FDA%20seeks%20input%20on%20the%20Priority%20List%20of%20Patient%20Preference-Sensitive%20Areas&utm_medium=email&utm_source=Eloqua

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