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


Manage episode 270527921 series 1533910
By K&L Gates and L Gates. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.

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

143 episodes