CBI's 2nd Annual Forum on Effective Preparation for FDA Advisory Committees - Online Compendium

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Item Number: C11Q016

Anticipate Challenges Prior to Notification-Streamline the Preparation Period-Achieve a Favorable Recommendation

Understand your Audience

Hear an in-depth profile of Advisory Committee members and how they approach their work
Develop tactics for addressing the interests, level of experience and commitment of panel
Learn about the FDA process and timeline to better anticipate timing for communication

Early Planning and Preparation

Think beyond safety and efficacy when building the development program
Apply learnings from previous Advisory Committee meetings to your new product's development

Advisory Committee Planning

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