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Federal enforcement officials investigating alleged unlawful acts by FDA-regulated companies have for decades scrutinized not only the activities of the companies but also the activities of individuals within the companies. More
FDA Enforcement Update — The Feds Target Corporate Officials Along With Companies
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In this white paper, Thompson FDA focuses on six areas of recent enforcement activity that have revealed the government’s priories as it identifies companies and corporate officials for investigation, brings civil and criminal actions against those companies and individuals... More
FDA Update: Recent Enforcement Blockbusters
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See our list of the 10 most important FDA and DEA developments of 2023 — and our view of what’s to come in the near future. More
Top 10 Recent FDA & DEA Developments — And What's Next in 2024
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This analysis from the experts at Thompson FDA unpacks the critical changes enacted under FDORA in the areas of FDA enforcement, clinical trial regulation, medical device regulation, and the regulation of medical product advertising and promotion. More
The Food and Drug Omnibus Reform Act of 2022
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The Dependable FDA Intelligence You Need: Trial the FDA Compliance Expert More
The Dependable FDA Intelligence You Need: Trial the FDA Compliance Expert
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New, Faster Pathways to Market for Medical Devices More
New, Faster Pathways to Market for Medical Devices
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In our weekly newsletter, get a sampling of the insight, analysis, and how-to compliance tools Thompson FDA provides on a regular basis to our subscribers. More
Thompson FDA News You Can Use
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FDA's Use of Inspections and Other Regulatory Oversight Tools During COVID-19 and Beyond: Welcome to the New Normal (Updated Edition) More
FDA's Use of Inspections and Other Regulatory Oversight Tools During COVID-19 and Beyond: Welcome to the New Normal (Updated Edition)
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9 Tips to Help You Pass Your Next FDA Inspection More
9 Tips to Help You Pass Your Next FDA Inspection
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What to Do When the FDA Comes Knocking: A Guide to Surviving FDA Inspections for Small Businesses More
What to Do When the FDA Comes Knocking: A Guide to Surviving FDA Inspections for Small Businesses
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FDA Enforcement Update — Recent Trends in Civil Settlements, Consent Decrees and Criminal Prosecutions More
FDA Enforcement Update — Recent Trends in Civil Settlements, Consent Decrees and Criminal Prosecutions
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New FDA Priorities for Medical Device Clinical Trials More
New FDA Priorities for Medical Device Clinical Trials
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Using Real-world Evidence in Clinical Trials: What Clinical Research Professionals and Product Sponsors Need to Know More
Using Real-World Evidence in Clinical Trials: What Clinical Research Professionals and Product Sponsors Need to Know
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9 Ways to Ace Your FDA Inspection Whitepaper More
9 Ways to Ace Your FDA Inspection Whitepaper
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On Feb. 22, 2022, the FDA released its long-awaited proposed rule that would align the agency’s quality system (QS) regulation more closely with ISO 13485, the internationally recognized consensus standard for device quality management systems (QMSs). More
The FDA’s Proposed Quality Management System Rule: New Responsibilities and Opportunities for Medical Device Companies
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Trends in FDA Enforcement: An Update on Agency Policy, Civil Settlements, Consent Decrees and Criminal Prosecutions More
Trends in FDA Enforcement: An Update on Agency Policy, Civil Settlements, Consent Decrees and Criminal Prosecutions

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