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The top documents tagged [fda advisory committee]
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fda advisory committee
11111 COX-2 FDA Advisory Committee Meeting 2005 Rofecoxib Speaker: Ned S. Braunstein, MD Senior Director, Merck Research Labs.
215 views
Office of New Drug Chemistry, OPS, CDER, Food and Drug Administration Establishing Dissolution Specification Current CMC Practice Vibhakar Shah, Ph.D.
219 views
FDA Advisory Committee Training An Industry Representative Perspective Alison Lawton Sr. VP Regulatory Affairs Genzyme Corporation.
218 views
Designing quality in Colin R Gardner, Currently: CSO, Transform Pharmaceuticals Inc Lexington, MA, 02421 Formerly: VP Global Pharmaceutical R&D Merck.
216 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.
228 views
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.
217 views
IRESSA: A journey of experience from broad to biomarker populations Claire Watkins Global Product Statistician, AstraZeneca EFSPI meeting on Oncology Basel,
215 views
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.
219 views
What is the Format & Content for a Premarket Approval (PMA) Submission? Carole C. Carey BSEE, MEng
[email protected]
Director, International Staff.
215 views
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