This Webinar will highlight the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be submitted in the marketing applications to FDA.

This Webinar will address the most pressing changes and answers questions FDA has received from industry and the public. While the “draft” offers much-needed clarification on certain regulatory requirements as well as invaluable insight into FDA’s current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.

Areas Covered in the Seminar:

• Review proposed changes to the 2011 released draft guidance.
• Clarification on definition of sponsor.
• Understand FDA's clear actions that can and will be taken regarding refuse to file a marketing application.
• Learn how to submit financial disclosure information to FDA.
• Why FDA is expounding on due diligence and its significance.
• Timing of data collection and purpose.
• Understand how financial information should be disclosed to FDA.
• Update regarding financial disclosure questionnaires.
• Time period covered by regulations.
• Clarification on covered clinical study.
• Factors for FDA review of disclosed financial interests.