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FDA Adverse Event Reporting System (FAERS): Practical Insights to Avoid 483s
FDA’s increasing scrutiny of postmarket data means the agency is looking to industry to provide transparency into the impact of their drug products on patients.
Do you know how to avoid the pitfalls?
Fail to properly identify and report an adverse event with FDA’s Adverse Event Reporting System (FAERS) and you get a 483. Fail to report within the required time frame and you get another.
Beyond the regulatory compliance ramifications, the newly publicly available FAERS dashboard — openFDA — provides exposure to your reported events and can influence choices by healthcare providers and patients alike when it comes to choosing your therapeutic product.
Ricki Chase, M.S., Executive Director at Lachman Consultant Services and a former FDA investigator, explains how you can avoid 483s — among other serious issues.
Presentation Takeaways:
- The difference between serious unexpected and serious expected events
- The reportability time frame, when the clock starts and how to avoid being a late filer
- Common FDA 483 observations related to adverse events and how to avoid them in your organization
- What not to report under the FAERS program
- How to handle combination product reporting
- The value of data, how to access data and what it reveals or means
Ensure your company’s compliance by avoiding FAERS-related 483s.