FDA Advisory Committee Preparation

and Health Authority Interactions

Since 1989, the CCA team has prepared clients for advisory committee in pursuing approval of over 100 indications (drugs, biologics, and devices), and our approach is easily adaptable to all of the 23 different drug/device/biologic advisory committees and panels.

We help clients to prepare for the full range of required health authority approvals. While we’re best known for helping clients prepare for FDA advisory committees, we also prepare sponsor teams for other agency related interactions, ranging from EOP1 to label negotiations. Our well-established preparation methods are also adaptable to other regulatory environments, including the EU approval process.

Our work ensures that team members anticipate all issues of interest to the health authority or advisory committee regarding their proposed drug or medical device. We help your key presenters develop and deliver data-driven sponsor’s presentations, and ready team members to effectively answer all questions, including retrieving convincing backup slides to support responses.

Our involvement begins with in-depth research, conducted through interviews and document analysis. We combine our experience with a review of your specific drug pharmacology and mechanism of action, preclinical research, clinical trials, adverse events, possible protocol violations, and efficacy issues in order to identify potential health authority and advisory committee concerns.

Following the research interviews and document analysis, we typically conduct a one-day strategy session focused on:

• Exploring data and issues uncovered in the research process
• Ranking issues based on risk to approval and strength of supportive evidence
• Discussing and assigning issue responders’ responsibilities
• Exploring key messages
• Formulating a rough sponsor presentation outline

We then guide your team through three or more intense, multi-day, “hands on” lab sessions to work on responses to drug approval issues and the development of sponsor presentations. During these sessions, we lead you through the creation of presentation tools, including a system for backup slide retrieval, and conduct extensive practice on the use of these tools. Each lab session culminates with a mock meeting that accurately simulates the environment and intensity of the upcoming event.