FDA's New Adverse Event Reporting Requirements -- What All OTC Drug Manufacturers Need to Know
Rick Stearns presented on FDA's New Adverse Event Reporting Requirements -- What All OTC Drug Manufacturers Need to Know, at the Center for Business Intelligence (CBI) webinar.
Topics that were discussed included:
- Who is (and is not) subject to the reporting requirements?
- What types of events need to be reported to FDA and how do you complete the forms?
- What records need to be maintained and what is FDA's authority to access them?
- If someone is injured, can the adverse event report be used against your company?
- Why are some parties unhappy with FDA's December 2007 guidance document?
- What are the penalties for non-compliance?
Date: Feb 21, 2008
Sponsors: Center for Business Intelligence (CBI)
Location: Webinar