Responding to 483s and Warning Letters: Strategies for High-Stakes Communications
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Fines, recalls, injunctions — how you respond to an FDA Form 483 should not be taken lightly. From timing to format to content, each step you take in analyzing the 483 and preparing your response can mean the difference between getting your product successfully to market and denial of access to the market.
With the stakes this high, why would anyone risk offering an unsatisfactory response? Yet it happens all the time ... poorly planned responses often result in warning letters stating the information was inadequate, incomplete, poorly written or unsatisfactory — and can lead to even bigger penalties down the road.
You can be confident in your response if your company receives a 483 when you sign up for this Encore presentation. Noted attorneys Fredrick H. Branding and Cathy L. Burgess will present best practices and lessons learned from decades of representing drug, device and biologics manufacturers. You'll walk away knowing how to assess the FDA's concerns and respond appropriately to avoid making common mistakes that result in warning letters. They'll analyze the language from actual 483 and warning letter responses and discuss why the response given was good or unsatisfactory.
These experts will thoroughly examine:
- How to analyze a 483 or warning letter — even when it isn't obvious what the FDA is expecting
- 10 essential dos and don'ts when writing your response to the FDA
- The proper structure of a response — the FDA is less likely to miss the good things you're doing if you provide the format they want to see
- Five common mistakes to avoid — now is not the time to wave a red flag
- The significance of making and keeping FDA commitments — showing good faith can go a long way
- Why developing timelines for corrective action plans is vital — it's not just what you do but when you do it
- The importance of supporting documentation — if you can't prove it, you didn't do it
Register now to listen to Responding to 483s and Warning Letters: Strategies for High-Stakes Communications. You'll get an opportunity to ask your toughest questions during the Q&A session.