The Principals at ECG have been involved in supporting clients with Oral Explanations (OEs) since the process began in 1995. Our experience spans numerous therapeutic areas and types of arguments (new product approval, conditional approvals, and post-marketing safety reviews).
Because Oral Explanations are time-restricted - the timeframe is typically minutes, not hours - they require strictly streamlined and compelling arguments as well as mechanisms and skills for supporting Q&A that are critical to garnering supportive commentary by this expert body. ECG's experiences in these meetings and their FDA counterparts have led to the development of a robust, time-tested preparation process.
Please contact us via email or at +1-201-894-8200 for more information about how we can improve your upcoming Oral Explanation.