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Dockets Management
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Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) and the Psychopharmacologic Drugs Advisory Committee (PDAC)

 

July 10, 2008

 

SLIDES

   

FDA Presentations

 

Antiepileptic Drugs and Suicidality: Statistical Review, Mark Levenson, Ph.D., Quantitative Safety and Pharmacoepidemiology Group Division of Biometrics 6/CDER/FDA (ppt) (html)

 

Antiepileptic Drugs and Suicidality: Background, Evelyn Mentari, M.D., M.S., Division of Neurology Products/CDER/FDA (ppt) (html)

 

Antiepileptic Drugs and Suicidality: Discussion, Evelyn Mentari, M.D., M.S., Division of Neurology Products/CDER/FDA (ppt) (html)

 

Preliminary Statistical Comments on Pfizer Gabapentin and Pregabalin Analysis, Mark Levenson, Ph.D., Quantitative Safety and Pharmacoepidemiology Group Division of Biometrics 6/CDER/FDA (ppt) (html)

 

 

Sponsor Presentation

Pfizer core presentation and backup files (pdf)

 

 

Open Public Hearing

 

OPH 1 (pdf) (html)

OPH 2 (pdf) (html)

OPH 3 (pdf) (html)

OPH 4 (pdf) (html)

OPH 5 (pdf) (html)

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Page last updated January 16, 2009->-> kkhorizonal rule
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