Office of Generic Drugs October 3-5, 2011 Presentations

• DMF (Type II) Review Team in the Office of Generic Drugs (PDF - 212KB)
  Aloka Srinivasan, Ph.D., Team Leader, DMF Review Team
• A Step-wise Procedure for Population Bioequivalence (PBE) Analysis of Orally Inhaled and Nasal Drug Product (OINDP) Bioequivalence Studies (PDF - 783KB)
  Bing V. Li, Ph.D., and Ke Ren, Ph.D., Division of Bioequivalence I
• Regulatory Update (PDF - 193KB)
  Craig Kiester, R.Ph., Division of Labeling and Program Support
• Emerging Stability Expectations in OGD, An Update (PDF - 88KB)
  Glen Smith, Director, Division of Chemistry II
• Labeling Updates and Overview  (PDF - 9.2MB)
  Jim Barlow, R.Ph., Division of Labeling and Program Support
• Regulatory Recommendations for ANDAs (PDF - 238KB)
  Kwadwo (Kojo) Awuah, Pharm.D., R.Ph., Division of Labeling and Program Support
• Scientific and Regulatory Considerations for Bioequivalence (BE) of Dry Powder Inhalers (DPIs) (PDF - 2.9MB)
  Sau (Larry) Lee, Ph.D., Science Staff/Immediate Office
• QbD Status Update for Generic Drugs  (PDF - 911KB)
  Susan Rosencrance, Ph.D., Deputy Director (Acting), Division of Chemistry II
• Product Equivalency – Considerations  (PDF - 178KB)
  Vilayat Sayeed, Ph.D., Director, Division of Chemistry III
• Bioequivalence Discussion Topics: All Bioequivalence Studies Rule Specific Products Guidance Process (PDF - 890KB)
  Barbara Davit, Ph.D., J.D., Acting Director, Division of Bioequivalence II
• Bioequivalence Update (PDF - 92KB)
  Dale Conner, Pharm.D., Director, Division of Bioequivalence I
• Safety Reporting Requirements for IND Exempt BA/BE Studies (PDF - 487KB)
  Debra Catterson, R.Ph., Division of Clinical Review
• Postmarketing Surveillance in the Office of Generic Drugs (PDF - 232KB)
  Dena R. Hixon, M.D., Division of Clinical Review
• From the Director (PDF - 218KB)
  Keith Webber, Ph.D., Deputy Director, OPS/Acting Director, OGD
• View from the Top  (PDF - 311KB)
  Keith Webber, Ph.D., Deputy Director, OPS/Acting Director, OGD
• Quality and Bioequivalence Standards for Narrow Therapeutic Index Drugs (PDF - 496KB)
  Lawrence Yu, Ph.D., Deputy Director for Science and Chemistry
• Current Issues Regarding Sterility Assurance Submissions for Sterile Generic Drug Products (PDF - 323KB)
  Lynne Ensor, Ph.D., Team Leader, Microbiology Division
• Microbiology Question-Based Review (Micro QbR) (PDF - 386KB)
  Neal Sweeney, Ph.D., Supervisory Microbiologist, Microbiology Division
• Recent Updates to the National Drug Code (NDC) Directory and Electronic Drug Registration and Listing System (eDRLS) (PDF - 434KB)
  Leyla Rahjou-Esfandiary, Soo Jin Park, and Paul Loebach, Office of Compliance