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Meeting Presentations (Drugs)

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.


2019 Presentations

Title Presenter(s) Date
Generic Drug Program Update Sally Choe, Ph.D. 04/01/2019
Search for Balance: FDA’s Approach to the Opioids Crisis (PDF - 2 MB) Douglas C. Throckmorton, MD 03/09/2019

2018 Presentations

Title Presenter(s) Date
Search for Balance: FDA’s Approach to the Opioids Crisis (PDF - 2 MB) Douglas C. Throckmorton, MD 03/09/2019
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 - 282KB) 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 - 1.34MB) Douglas C. Throckmorton, M.D. 11/14/2017
 State of OGD: Pivoting to GDUFA II (PDF - 1.3 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 - 818K B) 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 - 796KB) Sarah Barkow and Karen Takahashi 3/30/2017 
 The Public Health Role of Drug Regulation in the US (PDF - 1.0MB) Douglas C. Throckmorton, M.D. 3/20/2017
 FDA Perspective on Abuse-Deterrent Opioid Development (PDF - 1.15MB) Douglas C. Throckmorton, M.D. 3/7-8/2017
 Bridging Justifications: Supporting the Safety of Excipients in Generic Drug Products (PDF - 495KB) Robert T. Dorsam, Ph.D. 2/27/2017
 Compliance Trends (PDF - 725KB) Paula Katz 2/24/2017
 Future of Drug Development (PDF - 380KB) Janet Woodcock, M.D. 2/16/2017
 CDER 2016 Update for Rare Diseases (PDF - 546KB) Richard Moscicki, M.D.
 FDA Office of Generic Drugs (OGD) Keynote Address, GDUFA: Past, Present and Future (PDF -  475KB) Kathleen Uhl, M.D. 2/14/2017

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2016 Presentations

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

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2015 Presentations

Title Presenter(s) Date
 Office of Generic Drugs Director's Update: Reaping the Benefits of GDUFA (PDF - 1.1MB) Kathleen Uhl, M.D. 12/14/2015
 CDER 2016 Priorities (PDF - 115KB) Janet Woodcock, M.D. 12/14/2015
 CDER New Drug Review: 2015 Update (PDF - 1.3MB) John K. Jenkins, M.D. 12/14/2015
 New Requirement for Electronic Submission of DMFs (PDF - 1MB) Ginny Hussong 11/4/2015
 Dispute Resolution with CDER Options and Considerations (PDF - 480KB) Virginia L. Behr 10/27/2015
 CDER Formal Dispute Resolution: Appeals Above the Division Level (PDF - 491KB) Khushboo Sharma 10/27/2015
 FDA Perspective on Development of Abuse Deterrent Opioids: Have They Made Difference? (PDF - 382KB) Douglas C. Throckmorton, M.D. 10/22/2015
 Regulator-HTA-Funder Collaborations: Generic Market Forces in USA (PDF - 1.4MB) Douglas C. Throckmorton, M.D. 9/9/2015
 Current FDA Perspective & Future of JAS Testing to Support Pediatric Development Programs (PDF - 1.2MB) Karen Davis-Bruno, Ph.D. 7/14/2015
 CDER Breakthrough Therapy Program: What Happens Post-Designation? (PDF - 688KB) Miranda Raggio 6/17/2015
 Fighting Fakes (PDF - 198KB) Cynthia Schnedar, J.D. 6/2/2015
 Breakthrough Therapy Designation: An Analysis of the Past Two and a Half Years (PDF - 1MB) Kim Taylor 4/24/2015
 Applying the Breakthrough Criteria: Oncology, Neurology, Anti-Infective/Psychiatry/Hematology (PDF - 2MB) Multiple Presenters 4/24/2015
 Current CDER Initiatives (PDF - 768KB) Douglas C. Throckmorton, M.D. 4/20/2015
 FDA Perspective on Assessment of Drugs – Abuse Potential and Abuse Deterrence (PDF - 752KB) Douglas C. Throckmorton, M.D. 4/16/2015
 FDA Work on Medical Products Containing Marijuana(PDF - 518KB) Douglas C. Throckmorton, M.D. 3/14/2015
 Creating The Path to Success with GDUFA(PDF - 1.09MB) Kathleen Uhl, M.D. 2/10/2015
 GDUFA Regulatory Science Update(PDF - 220KB) Robert Lionberger, Ph.D. 2/10/2015
 A US Regulator’s View on Abuse Deterrent Formulations of Opioids(PDF - 55KB) Douglas C. Throckmorton, M.D. 2/3/2015
 Overview of FDA Support for Innovation (PDF - 683KB) Douglas C. Throckmorton, M.D. 2/2/2015
 Non-Clinical Cardiovascular Safety Testing: Moving Forward (PDF - 244KB) Douglas C. Throckmorton, M.D. 1/2015
 Selected FDA Activities on Opioids(PDF - 512KB) Douglas C. Throckmorton, M.D.  1/7/2015

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2013-2014 Presentations have been archived. To view them, please see the FDA Archive.