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3625. Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022
Subject(s):
Clinical Trials as Topic
Non-alcoholic Fatty Liver Disease -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3626. Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation: guidance for industry and Food and Drug Administration staff, and other stakeholders

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022
Subject(s):
Device Approval
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3627. Patient engagement in the design and conduct of medical device clinical studies: guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022
Subject(s):
Clinical Studies as Topic
Device Approval
Patient Participation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3630. Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 23, 2021
Subject(s):
Arthroscopy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration