Drug Safety & Risk Management Advisory Committee Meeting

May 18 & 19, 2005




                  Cover Letter by Paul Seligman, M.D. [Word] [PDF] [HTML]


Tab 3:      Federal Register Notice, “Drug Safety and Risk Management Advisory

Committee, Notice of Meeting,” April, 2005


Tab 10:    FDA Preliminary Concept Paper (Draft 4) “Clinical Evaluation of QT/QTc

                  Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic

                  Drugs”, June 10, 2004


Tab 11:   FDA Guidance for Industry: Premarketing Risk Assessment, dated March, 2005


Tab 12:    FDA Guidance for Industry: Good Pharmacovigilance Practices and

                  Pharmcoepidemiologic Assessment, dated March, 2005


Tab 13:   FDA Reviewer Guidance: Conducting a Clinical Safety Review of a New

  Product Application and Preparing a Report on the Review, dated February, 2005


        Bibliography  [Word] [PDF] [HTML]