Present Situation and Development Suggestion of Clinical Trials of Food for Special Medical Purpose
The implementation status of clinical trials of food for special medical purpose(FSMP)are analyzed comprehensively in this paper from six aspects,namely,the filing status of medical institutions,the research and development of total nutritional formula food for use in special diseases,protocol design and scientific assurance,institutional management and ethical review,subject compliance management and capacity building and collaborative cooperation of research team.Suggestions on the development of clinical trials of FSMP are put forward.
food for special medical purpose(FSMP)clinical trialtotal nutritional formula food for use in special diseasesquality management
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