June 14, 2018: Meeting Materials FDA Generated
Waiver for Steven D. Nathan, M.D. - June 14, 2018
Acknowledgment of Financial Interests for Steven D. Nathan, M.D. - June 14, 2018
Waiver for Bohdan M. Pichurko, M.D. - June 14, 2018
Acknowledgment of Financial Interests for Bohdan M. Pichurko, M.D. - June 14, 2018
Agenda: June 14, 2018
Roster: June 14, 2018
Draft Panel Questions: June 14, 2018
FDA Executive Summary: June 14, 2018
24 Hour Summary: June 14, 2018
FDA Presentation: June 14, 2018
Panel Questions : June 14, 2018
FDA Presentation (Additional Slides): June 14, 2018
Transcript: June 14, 2018
June 14, 2018: Meeting Materials Non-FDA Generated
Sponsor Executive Summary: June 14, 2018
Attachment 1 - Supplemental Tables: June 14, 2018
Attachment 2 - Detailed Summary of Additional Clinical Studies: June 14, 2018
Attachment 3 - Proposed Instructions for Use: June 14, 2018
Attachment 4 - Blibliography: June 14, 2018
Attachment 5 - Clinical Protocol: June 14, 2018
Attachment 6 - Statistical Analysis Plan: June 14, 2018
Attachment 7 - Proposed Post Approval Study Protocol: June 14, 2018
Sponsor Presentation - Introduction: June 14, 2018
Sponsor Presentation - Background: June 14, 2018
Sponsor Presentation - Trial Design: June 14, 2018
Sponsor Presentation - Development and Effectiveness: June 14, 2018
Sponsor Presentation - Safety Profile: June 14, 2018
Sponsor Presentation - Post Market Plan: June 14, 2018
Sponsor Presentation - Patient Preference: June 14, 2018
Sponsor Presentation - Clinical Context: June 14, 2018
Sponsor Presentation - Summation: June 14, 2018
Sponsor Presentation (Additional Slides): June 14, 2018
Content current as of:
09/20/2018
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