ABSTRACT
Introduction ....................................................................................................... 106 Types of FDA Meetings .................................................................................... 106
Pre-IND Meetings ........................................................................................ 106 End-of-Phase II Meetings ............................................................................ 107 Special Protocol Assessment and Ad Hoc Technical Meetings .................... 107 Pre-NDA/BLA Meetings .............................................................................. 107 Advisory Committee Meetings .................................................................... 107 Late Cycle Meetings .................................................................................... 108 Labeling Meetings ........................................................................................ 108 Postmarketing Requirement/Postmarketing Commitment, and Risk Evaluation and Mitigation Strategy Meetings .............................................. 108 Postaction Meetings ..................................................................................... 108 Biosimilar Biological Product Development Meetings ............................... 108
FDA Expectations ............................................................................................. 109 Preparing for FDA Meetings ..............................................................................111 Conduct at FDA Meetings .................................................................................114 Avoiding the Pitfalls ...........................................................................................115
