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Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

September 21, 2006

Slides

FDA

Trasylol® (aprotinin injection) Bayer Pharmaceuticals Corp. NDA 20-304, Dwaine Rieves, M.D., CDER (ppt) (htm)

Guest Speakers

Post-Marketing Safety Surveillance: Serine Protease Inhibitors & Anti-Fibrinolytics, Dennis Mangano, M.D., Ph.D, Ischemia Research and Education
Foundation (ppt) (htm)

Relative Efficacy and Safety of Aprotinin and Tranexamic Acid in Cardiac Surgery, Keyvan Karkouti, M.D, FRCPC, MSc Toronto General Research Institute (ppt) (htm)

Industry

Risk Benefit Review, Bayer Pharmaceuticals (pdf)

Open Public Hearing Speakers

Evaluation of Non-Randomized Studies, S. Stanley Young, National Institute of Statistical Sciences
(ppt) (htm)

Bruce D. Speiss, M.C., F.A.H.A. (pdf)

Outcomes Using Aprotinin Therapy, Linda Shore-Lesserson, M.D., Montefiore Medical Center, Bronx, New York (ppt) (htm)

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