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K&L Gates Triage: Q&A: What Sponsors and Investigators Need to Know about FDA's ClinicalTrials.gov Reporting Requirements

Date: 27 August 2020

FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On this week’s episode, Lindsey Rogers-Seitz and Kenneth Kennedy discuss the scope of FDA’s clinicaltrials.gov reporting requirements, as well as the penalties responsible parties may face for failing to meet them.

About Triage
Triage: Rapid Legal Lessons for Busy Health Care Professionals is a podcast created by the K&L Gates health care practice group to inform our clients and friends of the firm about the latest developments in health law. The K&L Gates Health Care practice will regularly create Triage podcasts to help you learn about the latest developments in health law. Our lawyers will identify the most important changes and analyze the impact of these changes on our clients. If you have feedback or would like to suggest a topic for a future episode, please contact us.

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Lindsey T. Rogers-Seitz
Lindsey T. Rogers-Seitz
Research Triangle Park
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Kenneth M. Kennedy
Kenneth M. Kennedy
Research Triangle Park
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