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  1. Center for Drug Evaluation and Research | CDER

Meeting Presentations | Drugs

 

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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.

2023 Presentations

Title Presenter(s) Date
Protecting Patients & Consumers from Drug Quality Risks (video) (PDF -  2.7 MB) Ruth Auguste, MA, Office of Pharmaceutical Quality 10/19/2023
2023 PDA/FDA Joint Regulatory Conference (PDF - 1 MB) Patrizia Cavazzoni, MD 9/18/2023
The State of Pharmaceutical Quality (PDF - 875 KB) Patrizia Cavazzoni, MD 6/22/2023
Some of CDER’s Top Issues, Priorities, and Goals (PDF - 1 MB) Patrizia Cavazzoni, MD 5/18/2023

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

Archived Presentations

    Older files are archived to keep our website running most efficiently.

    • Design of Clinical Trials (PDF - 1 MB) | Robert Temple, M.D. | 11/12/2013
    • 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.

    Resources

     
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