FDA Advisory Committee meetings can be convened for much more than just drug/device approval decisions. Most commonly, the topics of non-approval meetings are to discuss changes that will affect the development of certain types of products; clarify a regulatory pathway in need of public elucidation; or a review of accumulating data or post-marketing commitment study results that will add or detract from a currently approved product. All three require different types of advocacy tuned to the special needs of the topic at hand.
While all AdComm preparations require the same suite of service deliverables, it is the strategic novelty of each situation that brings out the best in ECG’s heavily experienced Principals. When venturing into subject areas where there is little to no precedent, regulatory communication experience and rhetorical expertise are of the utmost importance.
Our Principals have significant experience preparing teams for topics relating to public health impact, epidemiology, safety findings, regulatory clarifications and claims of corporate fraud or malfeasance. These meetings are high profile with reputational implications - and ECG has the specialized know-how, security services and technology that will make an important difference for your AdComm.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about our preparation for AdComms not for approval.