Communicating with the FDA takes place throughout the drug development life cycle, from protocol development through label negotiations. Collegial and productive communication helps both the Sponsor and the Agency navigate through the unique challenges that face each individual product, from drug to device to biologic.
During the pre-submission phase, there are often multiple opportunities to meet with the potential reviewers from the Agency. Meetings with the FDA review teams are complex activities that involve clear communicated content, persuasive speakers, and sensitivity to the multifaceted nature of such a critical interaction.
ECG has extensive experience preparing teams for meetings with FDA review teams. This experience includes messaging, document development, presentation development, Q&A development, meeting management, presentation training/coaching, Q&A training/coaching, and meeting behavior. In addition, ECG can also provide slide development and meeting logistics.
Another form of communication, the BLA / NDA / PMA, also requires principles of strategic communication. By matching our communication, rhetorical, and regulatory expertise to your needs, we assist you in building a persuasive scientific argument for your product.
If you are scheduled to appear before an Advisory Committee, this productive and consistent attention to messaging will enable you to expedite your preparation for the meeting.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about our FDA regulatory communication services.