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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. If you would like to provide feedback or would like to suggest a topic for a future episode of Triage, please contact us. Use the icons below to subscribe to Triage via your favorite podcast app to have our episodes delivered directly to you as they become available.

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

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

Aug 27, 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.

Presenters: Lindsey Rogers-Seitz and Kenneth Kennedy