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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![FDA-grass-iStock-1143843556]( "An Analysis Of The FDA’s Drug Shortages Root Cause Report")
An Analysis Of The FDA’s Drug Shortages Root Cause Report12/27/2019In Oct. 2019, the FDA's Drug Shortage Task Force published a report that identified root causes of drug shortages across the U.S. healthcare system and made recommendations for effectively resolving those underlying issues. This article summarizes the report's findings and discusses potential next steps the FDA may take.
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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.
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![opioid-crisis-flag]( "New FDA Powers Under The SUPPORT Act — What Pharma Manufacturers Need To Know")
New FDA Powers Under The SUPPORT Act — What Pharma Manufacturers Need To Know12/19/2018Drug manufacturers should be aware of new regulatory powers given to the FDA in a recently enacted law aimed at deterring opioid abuse. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) became law on Oct. 24, 2018 with bipartisan support in both the House and the Senate.
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![The FDA/EU Mutual Recognition Agreement — What You Need To Know]( "The FDA/EU Mutual Recognition Agreement — What You Need To Know")
The FDA/EU Mutual Recognition Agreement — What You Need To Know12/7/2017The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections to help determine whether statutory and regulatory requirements of the respective authorities have been met.
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![OIG HHS Logo]( "Insights On FDA: What We Can Learn From Two New U.S. Inspector General Reports")
Insights On FDA: What We Can Learn From Two New U.S. Inspector General Reports12/9/2016The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently released two reports that contain nuggets of interest to those who are watching for trends in the pharmaceutical industry.
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![quality chalkboard]( "5 Steps To Build A Quality Culture That Supports Data Integrity")
5 Steps To Build A Quality Culture That Supports Data Integrity9/20/2016When it comes to building a culture of quality, many companies ask, "Where do we start?” For those looking to instill good practices that will ensure the integrity of data, there are a wealth of recent resources to review.
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.