FDA
28th October 2014

Meeting Materials NOW Available! – edoxaban

October 30, 2014 8:00 a.m. to 5:30 p.m.: Cardiovascular and Renal Drugs Advisory Committee Meeting.

Meeting Materials NOW Available! – edoxaban

October 30, 2014 8:00 a.m. to 5:30 p.m.: Cardiovascular and Renal Drugs Advisory Committee Meeting 

Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.

During this meeting, the committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).

Please click HERE for the current roster of the Cardiovascular and Renal Drugs Advisory Committee.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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