| Presentation(s) | Title | Presenter(s) | Date |
|---|
 | CDER 2016 Actions and 2017 Priorities, Presentation at FDA CMS Summit, December 14, 2016 by Janet Woodcock M.D., Director, CDER, FDA (PDF - 118KB) | Janet Woodcock, M.D. | 12/14/2016 |
| CDER Office of Surveillance and Epidemiology: 2016 Update at the FDA CMS Summit (PDF - 1.16MB) | Gerald Dal Pan, M.D., MHS | 12/14/2016 |
| CDER New Drug Review: 2016 Update (PDF - 1.60MB) | John K. Jenkins, M.D. | 12/14/2016 |
| CDER Update and Priorities: 2016 (PDF - 298KB) | Richard Moscicki, M.D. | 12/8/2016 |
| Reforming Clinical Trials in Drug Development: Impact of Targeted Therapies (PDF - 502KB) | Janet Woodcock, M.D. | 11/16/2016 |
| CDER and Research Progress Update on Opioid Action Plan (PDF - 814KB) | Douglas C. Throckmorton M.D. | 11/15/2016 |
| Putting the ‘Quality’ in Quality Agreements for Contract Manufacturing Operations (PDF - 574KB) | Paula Katz | 11/3/2016 |
| Implications of Draft Guidelines on Abuse Liability Testing for Generic Opioids (PDF - 613KB) | Douglas C. Throckmorton M.D. | 11/2/2016 |
| Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products – Framing the Meeting (PDF - 524KB) | Douglas C. Throckmorton M.D. | 10/31/2016 |
| Biosimilars in the US: Progress and Promise (PDF - 268KB) | John K. Jenkins, M.D. | 10/27/2016 |
| CGMP Compliance Considerations for Combination Product Manufacturing (PDF - 343KB) | Sarah Barkow | 10/25/2016 |
| Inspections and ANDA Review: CDER/OC/OMQ’s Role
(PDF - 239KB) | Francis Godwin | 10/25/2016 |
| Office of Generic Drugs Director's Update (PDF - 2MB) | Kathleen Uhl, M.D. | 10/24/2016 |
| Regulatory Flexibility and Lessons Learned: Drugs for Rare Diseases (PDF - 397KB) | John K. Jenkins, M.D. | 10/18/2016 |
| Regulatory Perspective: Data Integrity Guidance/Policy
(PDF - 408KB) | Paula Katz | 9/14/2016 |
| NIDA Clinical Trial Endpoints for Cannabis Use Disorder: an FDA View (PDF - 452KB) | Douglas C. Throckmorton M.D. | 9/12/2016 |
| Managing Risk to Quality: the Good and the Bad (PDF - 1.7MB) | David Jaworski | 6/7/2016 |
| The Importance of Assuring Quality Throughout the Lifecycle (PDF - 1.52MB) | Richard Friedman, M.S. | 6/6/2016 |
| Current Expectations and Guidance, including Data Integrity and Compliance with CGMP (PDF - 445KB) | Sarah Barkow, Ph.D. | 6/5/2016 |
| Overview of the Over-the-Counter Drug Monograph Process (PDF - 1.53 MB) | Karen Murry Mahoney, M.D. | 6/10/2016 |
| Setting the Stage: Current Access Policy Challenges and Initiatives (PDF - 839 KB) | Douglas C. Throckmorton, M.D. | 6/9/2016 |
| Clinical Implications of Drug Shortages: FDA Perspective (PDF - 507 KB) | Douglas C. Throckmorton, M.D. | 6/6/2016 |
| FDA Update 2016 - CHPA 2016 Scientific, Regulatory and Quality Conference (PDF - 380KB) | Douglas C. Throckmorton, M.D. | 5/19/2016 |
| Expanded Access to Investigational Drugs and Biologics (PDF - 1.22MB) | Richard Klein | 5/16/2016 |
| Expanded Access Programs for Drugs and Biologics (PDF - 61KB) | Richard Moscicki, M.D. | 5/16/2016 |
| FDA Policies and Actions Related to the Development and Use of Opioids to Treat Pain (PDF - 531 KB) | Douglas C. Throckmorton M.D. | 5/12/2016 |
| FDA Regulation of Marijuana: Past Actions, Future Plans (PDF - 1.2MB) | Douglas C. Throckmorton, M.D. | 4/12/2016 |
| Presentations from the Office of Manufacturing Quality | Two Presenters | 3/2016 |
| Office of Generic Drugs Director's Update (PDF - 1.1MB) | Kathleen Uhl, M.D. | 2/24/2016 |
| Title I Implementation - Pharmacy Compounding in 2016 (PDF - 84KB) | Jane A. Axelrad | 2/23/2016 |
