GPhA 2015 Annual Meeting
- Creating The Path to Success with GDUFA (PDF - 1.09MB)Kathleen Uhl, M.D.
Office Director, OGD
- GDUFA Regulatory Science Update (PDF - 220KB)Robert Lionberger, Ph.D.
Director, Office of Research and Standards, OGD
GPhA 2014 Fall Technical Conference
- GDUFA Goal Dates: It’s Not Just About the Numbers – Building a Quality System (PDF)
Kathleen Uhl, M.D.
Office Director (Acting), OGD
- Bioequivalence and Regulatory Science Initiatives - Bioequivalence and Safety of Generic Drug Products with an Alternative Route of Administration (PDF)
Minglei Cui, Ph.D.
Team leader, Division of Bioequivalence II, Office of Bioequivalence, OGD
- Inactive Ingredients - Evaluating the Safety of Inactive Ingredients in Generic Pharmaceuticals (PDF)
Elena Braithwaite, Ph.D., DABT
Staff Fellow, OGD
- Project Manager Update (OGD/OPS(OPQ)/Industry) (PDF)
Denise Toyer McKan, Pharm.D.
Director, Division of Project Management, OGD
- User Fees According to Goldilocks: Getting Your User Fees *Just* Right (PDF)
Donal Parks, MBA, MPM
Director, Division of User Fee Management and Budget Formulation, Office of Management
- Guidance for Industry: ANDA Submissions –Refuse-to-Receive Standards (PDF)
Johnny Young, R.Ph.
Division Director (Acting), Division of Filing Review, OGD
- Common Deficiencies with Bioequivalence Submissions in ANDAs (PDF)
Wayne Dehaven, Ph.D.
Director (Acting), Division of Bioequivalence I, Office of Bioequivalence, OGD
- Developing New Bioequivalence Approaches for Complex Products (PDF)
Robert Lionberger, Ph.D.
Director (Acting), Office of Research and Standards, OGD
- GDUFA Implementation:Years 1 and 2 (PDF)
Martha Nguyen, J.D.
Senior Policy Advisor, OGD
Other GPHA Meetings
- UPDATE on GDUFA and FDA’s Office of Generic Drugs (PDF - 1MB)
Kathleen Uhl, MD, Feb 20, 2014
- Life with GDUFA (PDF - 983MB)
Kathleen Uhl, MD, Oct 30, 2013
- Complex Generic Drugs (PDF - 331KB)
Robert Lionberger, Oct 29, 2013
- Welcome and Introduction – Update on Changes to API Review in OGD (PDF - 132KB)
Dave Skanchy, Ph.D., Oct 28, 2013
- Stability - The Current Status (PDF - 298KB)
Susan Rosencrance, Ph.D., Oct 28, 2013
- Drug Master File- Project Management Perspective (PDF - 135KB)
CDR Kun Shen, Ph.D.,M.S.,BCPS Oct, 2013
- Completeness Assessment for Type II Active Pharmaceutical Ingredient Drug Master Files to Be Referenced in ANDAs (PDF - 1.41MB)
Huyi Zhang, Ph.D., Oct 28, 2013
- Common Incomplete Comments Observed in Completeness Assessment of Type II API DMF (PDF - 144KB)
Haitao Li, Ph.D., Oct 28, 2013
- Manufacturing Process Development (PDF - 107KB)
Ramnarayan Randad, Oct 28, 2013
- Compliance and Quality (PDF - 870KB)
Douglas W. Stearn, Oct, 2013
- QbR for API’s Session II: Updates and Revisions (PDF - 300KB)
Deborah Johnson, Ph.D., Oct 28, 2013
- Quality Metrics--Why are we going...Where are we going... (PDF - 196KB)
Russell Wesdyk, Oct, 2013
- GDUFA Completeness Assessment Matrix Study in the First Six-Month (PDF - 194KB)
Wei Song, Ph.D., Oct, 2013
- Generic Drug Electronic Self-Identification (PDF - 1MB)
Monica Bali, Sept 11, 2013
- FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2013 Presentation Slides
Multiple Presenters, Jun 19-20, 2013
- 2013 GDUFA and You Conference Presentation Slides
Multiple Presenters, Jun 12-13, 2013
- Generic Drug User Fee Amendments of 2012 (PDF - 234KB)
Russell Wesdyk, FDA, Office of Pharmaceutical Science
- PDUFA, MDUFMA and GDUFA: What Lies Ahead (PDF - 109KB)
Peter C. Beckerman, FDA, at Health Leaders Dialogue, Feb. 10, 2011
- Remarks at the 2012 GPhA Annual Meeting
Margaret A. Hamburg, M.D., Commissioner of Food and Drugs
- Testimony -- FDA User Fees 2012: How Innovation Helps Patients and Jobs
Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research