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5. Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff

Publication:
Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
Subject(s):
Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Unique device identification: Policy regarding compliance dates for class I and unclassified devices, direct marking, and Global Unique Device Identification Database requirements for certain devices : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 25, 2022
Subject(s):
Databases as Topic
Equipment and Supplies
Government Regulation
Product Labeling
United States
United States. Food and Drug Administration

7. State all payer claims databases: identifying challenges and opportunities for conducting patient-centered outcomes research and multi-state studies

Author(s):
Kranz, Ashley M., author
Dworsky, Michael, author
Ryan, Jamie, author
Heins, Sara E., author
Bhandarkar, Mallika, author
Publication:
[Washington, D.C.] : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation ; [Santa Monica, California] : RAND Health Care, October 2023
Subject(s):
Databases as Topic
Patient Outcome Assessment
State Government
United States