Effective communication with FDA is critical in successfully bringing any therapeutic product to market. However, communication includes much more than the written regulatory submission. Effective communication with FDA in all its forms must be concise, carefully considered, and reviewed to achieve the desired outcome.
One must ask several questions before engaging in correspondence with FDA. When are we required to communicate with FDA? More importantly, when should we communicate with FDA? What should we say and how should we say it? What should we not say and how should we not say it? It’s not what you say that matters – it’s what people hear!
Using the case study approach, all of these questions and others will be answered in an interactive fashion, including:
- When are we required to communicate with FDA? When should we? Is it ever too early?
- What should we say and how should we say it? What should we not say and how should we not say it?
- Who should communicate with FDA and who should not? When should it be verbal, and when in writing?
- When should we communicate formally vs. informally?
- How do we avoid timely and costly mistakes and how can we use creative ways to use communication with FDA to our advantage!