Office of Generic Drugs October 20-21, 2010 Presentations

• Excipients – Best Practices for Identification and Support of Excipients in ANDAs (PDF - 107KB) Iain Margand, R.Ph., Regulatory Support Management Officer
• Bioequivalence Issues 1 (PDF - 55KB) Dale Conner, Pharm.D., Director, Division of Bioequivalence I
• Bioequivalence Issues 2 (PDF - 77KB) Chandra Chaurasia, Ph.D., R.Ph., Team Leader, Division of Bioequivalence II
• Drug Safety Considerations for ANDAs 1 (PDF - 376KB) Debra Catterson, R.Ph., Clinical Safety Coordinator
• Drug Safety Considerations for ANDAs 2 (PDF - 74KB) Dena Hixon, M.D., Associate Director for Medical Affairs
• 180-Day Exclusivity Forfeiture Review (PDF - 88KB) Susan Levine, J.D., Regulatory Counsel
• Question-based Review for Microbiology 1 (PDF - 257KB) Lynne Ensor, Ph.D., Team Leader, Microbiology Review Team
• Question-based Review for Microbiology 2 (PDF - 258KB) Neal Sweeney, Ph.D., Team Leader, Microbiology Review Team
• OGD Chemistry Review Function: An Update (PDF - 109KB) Lawrence Yu, Ph.D., Deputy Director for Science and Chemistry
• Common Deficiencies: QbR/Lessons Learned (PDF - 115KB) Aloka Srinivasan, Ph.D. Team Leader, Division of Chemistry III and Robert Iser, M.S., Acting Director, Division of Chemistry IV
• Quality by Design for Generic Drugs (PDF - 197KB) Laxma Nagavelli, Ph.D., Acting Team Leader, Division of Chemistry III
• Chemistry, Manufacturing and Control Updates: Panel Discussion (PDF - 53KB) Robert Iser, M.S., Acting Director, Division of Chemistry IV; Paul Schwartz, Ph.D., Acting Director, Division of Chemistry I; Lawrence Yu, Ph.D., Deputy Director for Science and Chemistry
• Office of Generic Drugs Director's Roundtable (PDF - 139KB) Keith Webber, Ph.D., Acting Director