Meeting Presentations | Drugs
CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users fees, to drug advertising and marketing, to genomics, to over-the-counter products. Materials and overviews from some of those meetings are listed in the presentations library.
2021 Presentations
Title | Presenter(s) | Date |
---|---|---|
Use of Bayesian Hierarchical Models in the Presentation of Subgroup Analyses (PDF - 757 KB) | Mark Rothmann | 11/19/2021 |
Understanding Regulatory Expectations for Post-Approval Changes in ANDAs (PDF - 573 KB) | Olugbenga “Gbenga” Okubadejo, PharmD | 11/10/2021 |
Association for Accessible Medicines GRx+Biosims 2021 (PDF - 959 KB) | Sally Choe, Ph.D. | 11/9/2021 |
FDA’s Emergency Use Authorization: Lessons Learned from the Past to Guide the Future (PDF - 656 KB) | Patrizia Cavazzoni, MD | 10/5/2021 |
Advancing Efficient and Inclusive Clinical Trials (PDF - 696 KB) | Patrizia Cavazzoni, MD | 10/4/2021 |
2021 PDA/FDA Joint Regulatory Conference (PDF - 859 KB) | Patrizia Cavazzoni, MD | 9/27/2021 |
FDA Role in Regulation of Cannabis Products (PDF - 1.67 MB) | Douglas C. Throckmorton, MD | 9/16/2021 |
State of CDER 2021 (PDF - 690 KB) | Patrizia Cavazzoni, MD | 5/20/2021 |
2020 Presentations
Title | Presenter(s) | Date |
---|---|---|
State of CDER 2020 (PDF - 431 KB) | Patrizia Cavazzoni, MD | 10/8/2020 |
2019 Presentations
Title | Presenter(s) | Date |
---|---|---|
CDER New Drugs Program: 2019 Update (PDF - 1.32MB) | Khushboo Sharma, MBA, RAC | 12/3/2019 |
Generic Drug Program Update (PDF - 135 KB) | Sally Choe, PhD | 4/2019 |
New Drugs Regulatory Program Modernization (PDF - 167 KB) | Janet Woodcock, MD | 4/2019 |
Search for Balance: FDA’s Approach to the Opioids Crisis (PDF - 2 MB) | Douglas C. Throckmorton, MD | 3/9/2019 |
FDA Role in Regulation of Cannabis Products (PDF - 88 KB) | Sharon Lindan Mayl, J.D. | 2/2019 |
Ongoing FDA Work Related to Opioid Overdose Prevention (PDF - 1.5 MB) | Douglas C. Throckmorton, MD | 1/2019 |
2018 Presentations
Title | Presenter(s) | Date |
---|---|---|
Search for Balance: FDA’s Approach to the Opioids Crisis (PDF - 2 MB) | Douglas C. Throckmorton, MD | 3/9/2019 |
Federal Efforts to Prevent Drug Shortages An FDA Perspective (PDF - 66 KB) | Douglas C. Throckmorton, MD | 12/27/2018 |
Charge to the Committee (PDF - 1MB) | Douglas C. Throckmorton, MD | 12/13/2018 |
Addressing Opioids: The FDA Response to Challenges in Public Health (PDF - 1 MB) | Douglas C. Throckmorton, MD | 12/12/2018 |
CDER New Drugs Program: 2018 Update (PDF - 977 KB) | Khushboo Sharma, MBA, RAC | 12/11/2018 |
CDER Office of Surveillance and Epidemiology: 2018 Update (PDF - 2 MB) | Gerald J. Dal Pan, MD, MHS | 12/11/2018 |
FDA Update on Drug Compounding (PDF - 1 MB) | Julie Dohm, J.D., Ph.D. | 10/04/2018 |
FDA Center Updates: CDER (PDF - 409 KB) | Douglas C. Throckmorton, M.D. | 9/26/2018 |
OGD Update: Welcome to much more than GDUFA II (PDF - 847 KB) | Kathleen Uhl, M.D. | 9/7/2018 |
FDA Update: 2018 (PDF - 975 KB) | Douglas C. Throckmorton, M.D. | 5/21/2018 |
FDA Update: 2018 (PDF - 1 MB) | Douglas C. Throckmorton, M.D. | 5/17/2018 |
Update: Biosimilar Program in the U.S. (PDF - 236 KB) | Leah Christl, Ph.D. | 4/27/2018 |
Biosimilar Regulatory Policy: Understanding the Landscape and Relevance to Medical Practice (PDF - 584 KB) | Sue Lim, M.D. | 4/14/2018 |
Biosimilar and Interchangeable Products: The U.S. FDA Perspective (PDF - 313 KB) | Joe Franklin, J.D., Ph.D. | 4/14/2018 |
FDA's Actions to Address the Opioid Epidemic (PDF - 1MB) | Douglas C. Throckmorton, M.D. | 3/14/2018 |
The Role of Social Science in Prescription Drug Promotion at FDA and Preview of Upcoming Studies (PDF - 282 KB) | Kathryn J. Aikin, Ph.D. | 3/9/2018 |
2017 Presentations
Title | Presenter(s) | Date |
---|---|---|
Center for Drug Evaluation and Research - Compliance Central with FDA Center Compliance Directors: Part 1 (PDF - 810 KB) |
Donald D. Ashley, JD | 12/6/2017 |
CDER Update (PDF - 88 KB) | Janet Woodcock, MD | 12/5/2017 |
CDER Office of Surveillance and Epidemiology: 2017 Update (PDF - 3.6 MB) | Gerald J. Dal Pan, MD, MHS | 12/5/2017 |
CDER New Drugs Program: 2017 Update (PDF - 543 KB) | Patrick Frey | 12/5/2017 |
FDA's Role in Confronting the Opioid Epidemic (PDF - 1 MB) | Douglas C. Throckmorton, M.D. | 11/14/2017 |
State of OGD: Pivoting to GDUFA II (PDF - 1 MB) | Kathleen Uhl, M.D. | 11/6/2017 |
FDA's Role in Confronting the Opioid Epidemic (PDF - 823 KB) | Douglas C. Throckmorton, M.D. | 10/12/2017 |
FDA's Role in Confronting the Opioid Epidemic (PDF - 818 KB) | Douglas C. Throckmorton, M.D. | 9/18/2017 |
The Collaborative for Effective Prescription Opioids quarterly meeting on September 12, 2017 (PDF - 336 KB) | Douglas C. Throckmorton, M.D. | 9/12/2017 |
FDA Role in Marijuana Regulation (PDF - 851 KB) | Douglas C. Throckmorton, M.D. | 7/19/2017 |
Current Expectations and Guidance, Including Data Integrity and Compliance with CGMP (PDF - 796 KB) | Sarah Barkow and Karen Takahashi | 3/30/2017 |
The Public Health Role of Drug Regulation in the US (PDF - 1 MB) | Douglas C. Throckmorton, M.D. | 3/20/2017 |
FDA Perspective on Abuse-Deterrent Opioid Development (PDF - 1 MB) | Douglas C. Throckmorton, M.D. | 3/7-8/2017 |
Bridging Justifications: Supporting the Safety of Excipients in Generic Drug Products (PDF - 495 KB) | Robert T. Dorsam, Ph.D. | 2/27/2017 |
Compliance Trends (PDF - 725 KB) | Paula Katz | 2/24/2017 |
Future of Drug Development (PDF - 380 KB) | Janet Woodcock, M.D. | 2/16/2017 |
CDER 2016 Update for Rare Diseases (PDF - 546 KB) | Richard Moscicki, M.D. | 2/16/2017 |
FDA Office of Generic Drugs (OGD) Keynote Address, GDUFA: Past, Present and Future (PDF - 475 KB) | Kathleen Uhl, M.D. | 2/14/2017 |
2016 Presentations have been archived. To view them, please see the FDA Archive
2012-2015 Presentations have been archived. To view them, please see the FDA Archive.
2012-2015 Presentations have been archived. To view them, please see the FDA Archive.