ARTICLES BY CYNTHIA SCHNEDAR
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![Ticket]( "Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty?")
Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty?10/27/2020The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.
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![data security]( "What Does IMDRF's New Cybersecurity Guidance Mean For You?")
What Does IMDRF's New Cybersecurity Guidance Mean For You?12/2/2019Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.
Cynthia Schnedar
Cynthia Schnedar is executive VP of regulatory compliance at Greenleaf Health. She was formerly director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER). During her time at FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA commissioner, the CDER director, and other senior FDA officials on significant enforcement issues. Cynthia spent more than two decades at the Department of Justice (DoJ), where she specialized in compliance and enforcement issues and served as acting inspector general. She earned a B.A. from the University of New Mexico and a J.D. from the University of Texas School of Law. You can connect with her on LinkedIn.