Acknowledgments. ......................................................................................................1
Introduction.................................................................................................................. 2
ANALYSIS
Chapter 1: Prepare Early. ...........................................................................................14
Chapter 2: Convene the Team. ..................................................................................24
Chapter 3: Target the Audience. ................................................................................35
Chapter 4: Engage Stakeholders. ..............................................................................41
Chapter 5: Dissect the Data. ......................................................................................49
CONTENT DEVELOPMENT
Chapter 6: Build the Right Foundation....................................................................... 55
Chapter 7: Make a Good First Impression. ................................................................63
Chapter 8: Tell the Story............................................................................................. 71
Chapter 9: Visualize the Data ....................................................................................77
Chapter 10: Be Ready with Backup............................................................................ 91
Chapter 11: Check It. Check It Again. ........................................................................98
TESTING &TRAINING
Chapter 12: Stand and Deliver. ................................................................................104
Chapter 13: Respond and Resolve........................................................................... 111
Chapter 14: Get a Reality Check. .............................................................................123
Chapter 15: Speak to the Street............................................................................... 131
Chapter 16: Amplify the Message. ..........................................................................139
FINAL PREPARATION &MEETING EXECUTION
Chapter 17: Game On!.............................................................................................. 146
CLOSING
Chapter 18: A Final Word. ........................................................................................153
LOGISTICS &CONTEXT
Appendix I: Listing of the FDA’s Advisory Committees............................................ 155
Appendix II: Rx-to-OTC Switches. ............................................................................158
Appendix III: New Drug Application (NDA) Review Process.................................... 162
Appendix IV: Legislative and Regulatory Considerations .......................................163
Appendix V: Glossary............................................................................................... 164
CONTENTS
Introduction.................................................................................................................. 2
ANALYSIS
Chapter 1: Prepare Early. ...........................................................................................14
Chapter 2: Convene the Team. ..................................................................................24
Chapter 3: Target the Audience. ................................................................................35
Chapter 4: Engage Stakeholders. ..............................................................................41
Chapter 5: Dissect the Data. ......................................................................................49
CONTENT DEVELOPMENT
Chapter 6: Build the Right Foundation....................................................................... 55
Chapter 7: Make a Good First Impression. ................................................................63
Chapter 8: Tell the Story............................................................................................. 71
Chapter 9: Visualize the Data ....................................................................................77
Chapter 10: Be Ready with Backup............................................................................ 91
Chapter 11: Check It. Check It Again. ........................................................................98
TESTING &TRAINING
Chapter 12: Stand and Deliver. ................................................................................104
Chapter 13: Respond and Resolve........................................................................... 111
Chapter 14: Get a Reality Check. .............................................................................123
Chapter 15: Speak to the Street............................................................................... 131
Chapter 16: Amplify the Message. ..........................................................................139
FINAL PREPARATION &MEETING EXECUTION
Chapter 17: Game On!.............................................................................................. 146
CLOSING
Chapter 18: A Final Word. ........................................................................................153
LOGISTICS &CONTEXT
Appendix I: Listing of the FDA’s Advisory Committees............................................ 155
Appendix II: Rx-to-OTC Switches. ............................................................................158
Appendix III: New Drug Application (NDA) Review Process.................................... 162
Appendix IV: Legislative and Regulatory Considerations .......................................163
Appendix V: Glossary............................................................................................... 164
CONTENTS