For a sponsor whose product is to be the subject of an Advisory Committee meeting, thorough and effective meeting preparation is vital. ECG excels at providing such preparation.
From developing communication strategy and messages, to AdComm member profiling, marshalling effective support, creating visuals, and identifying issues and responses through speaker coaching, mock meetings, Q&A rehearsal, and debriefing, ECG makes your team ready.
During an Advisory Committee meeting, both the FDA and the sponsor of the product present their research concerning the product. The committee then asks questions about that research, bringing to such discussions their expertise and experience as physicians and researchers or patient and consumer representatives. Other interested parties may speak during an Open Public Hearing. Before a vote is taken, the Advisory Committee returns to a discussion of the points and conclusions raised by the FDA and sponsor.
It then votes on the questions FDA has presented, and while the FDA is not bound by that vote, it usually follows the recommendations of the Advisory Committee.
Not every Advisory Committee meeting results in a vote; at times its purpose is to discuss policy, research methods, or requirements; these meetings still often include sponsors of products used in the therapeutic area under discussion.
ECG has had exceptional experience with most FDA Advisory Committees over the past 30 years and more than 150 successful AdComm meetings. For many committees, our experience is second to none. Some committees we have exceptional experience with are:
Please contact us via email or at +1-201-894-8200 with any questions or for more information about our FDA Advisory Committee meeting preparation.