What is it about?
U.S. Food and Drug Administration observations of various aspects of biomedical research as observed through inspections of Clinical Investigators, Pre-Clinical Laboratories, Institutional Review Boards, Sponsors, and Sponsor-Investigators. Inspections have shown an increase in compliance with the laws and regulations but significant improvements can still be made.
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Why is it important?
The laws and regulations governing biomedical research, in particular human subject research, covers not only legal but ethical commitments researchers have taken to ensure data that is both valid and ethically obtained. Given past transgressions by the research community, the public must be confident in the individuals performing these experiments and the data obtained from them.
Perspectives
Given my many years of experience in the auditing of pre-clinical and clinical medical research, I have seen the negative effects on subjects and the data obtained from research stakeholders that do not comply with U.S. Food and Drug Administration's laws and regulations. Providing as much detailed information and analysis of this information to all research stakeholders as possible will hopefully ensure compliance and assure to individuals in the private sector, public sector, and the general public for future studies.
Craig Garmendia
U.S. Food and Drug Administration
Read the Original
This page is a summary of: Research Deviations in FDA-Regulated Clinical Trials, Therapeutic Innovation & Regulatory Science, January 2018, SAGE Publications,
DOI: 10.1177/2168479017751405.
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