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The top documents tagged [fda advisory committee]

Statistical Issues in the Design, Conduct and Analysis of Large Safety Studies Michael Gaffney, PhD Pfizer Inc
Statistical Issues in the Design, Conduct and Analysis of Large Safety Studies Michael Gaffney, PhD Pfizer Inc
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11111 COX-2 FDA Advisory Committee Meeting 2005 Rofecoxib Speaker: Ned S. Braunstein, MD Senior Director, Merck Research Labs
11111 COX-2 FDA Advisory Committee Meeting 2005 Rofecoxib Speaker: Ned S. Braunstein, MD Senior Director, Merck Research Labs
216 views
FDA ADVISORY COMMITTEE: Neonatal Opioid Withdrawal Syndrome ANNE JOHNSTON, MD Neonatal Perinatal Medicine Associate Professor of Pediatrics University
FDA ADVISORY COMMITTEE: Neonatal Opioid Withdrawal Syndrome ANNE JOHNSTON, MD Neonatal Perinatal Medicine Associate Professor of Pediatrics University
224 views
Office of New Drug Chemistry, OPS, CDER, Food and Drug Administration Establishing Dissolution Specification Current CMC Practice Vibhakar Shah, Ph.D
Office of New Drug Chemistry, OPS, CDER, Food and Drug Administration Establishing Dissolution Specification Current CMC Practice Vibhakar Shah, Ph.D
222 views
FDA Advisory Committee Training An Industry Representative Perspective Alison Lawton Sr. VP Regulatory Affairs Genzyme Corporation
FDA Advisory Committee Training An Industry Representative Perspective Alison Lawton Sr. VP Regulatory Affairs Genzyme Corporation
225 views
Designing quality in Colin R Gardner, Currently: CSO, Transform Pharmaceuticals Inc Lexington, MA, 02421 Formerly: VP Global Pharmaceutical R&D Merck
Designing quality in Colin R Gardner, Currently: CSO, Transform Pharmaceuticals Inc Lexington, MA, 02421 Formerly: VP Global Pharmaceutical R&D Merck
219 views
Risk-Based CMC Review Paradigm Moheb M. Nasr, Ph.D. Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee for Pharmaceutical Science Manufacturing
Risk-Based CMC Review Paradigm Moheb M. Nasr, Ph.D. Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee for Pharmaceutical Science Manufacturing
234 views
What FDA Failed to Disclose 1991, 2006 Vera Hassner Sharav Alliance for Human Research Protection
What FDA Failed to Disclose 1991, 2006 Vera Hassner Sharav Alliance for Human Research Protection
213 views
FDA Advisory Committee for Pharmaceutical Science—March 13, 2003 Carlos R. Hamilton, Jr. MD, FACE American Association of Clinical Endocrinologists—Vice
FDA Advisory Committee for Pharmaceutical Science—March 13, 2003 Carlos R. Hamilton, Jr. MD, FACE American Association of Clinical Endocrinologists—Vice
220 views
IRESSA: A journey of experience from broad to biomarker populations Claire Watkins Global Product Statistician, AstraZeneca EFSPI meeting on Oncology Basel,
IRESSA: A journey of experience from broad to biomarker populations Claire Watkins Global Product Statistician, AstraZeneca EFSPI meeting on Oncology Basel,
216 views
Deborah Hursh, Ph.D. Office of Cellular, Tissue, and Gene Therapies
Deborah Hursh, Ph.D. Office of Cellular, Tissue, and Gene Therapies
26 views
0 Cardima, Inc.’s Revelation Tx Microcatheter with NavAblator ™ RF Ablation System FDA Circulatory System Devices Panel Meeting P020039 May 29, 2003
0 Cardima, Inc.’s Revelation Tx Microcatheter with NavAblator ™ RF Ablation System FDA Circulatory System Devices Panel Meeting P020039 May 29, 2003
224 views