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                Center for Drug Evaluation and Research | CDER

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          Meeting Presentations | DrugsCenter 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)
			DateProtecting Patients & Consumers from Drug Quality Risks (video) (PDF -  2.7 MB)
			Ruth Auguste, MA, Office of Pharmaceutical Quality
			10/19/20232023 PDA/FDA Joint Regulatory Conference (PDF - 1 MB)
			Patrizia Cavazzoni, MD
			9/18/2023The State of Pharmaceutical Quality (PDF - 875 KB)
			Patrizia Cavazzoni, MD
			6/22/2023Some of CDER’s Top Issues, Priorities, and Goals (PDF - 1 MB)
			Patrizia Cavazzoni, MD
			5/18/2023

2021 Presentations

Title
			Presenter(s)
			DateUse of Bayesian Hierarchical Models in the Presentation of Subgroup Analyses (PDF - 757 KB)
			Mark Rothmann
			11/19/2021Understanding Regulatory Expectations for Post-Approval Changes in ANDAs (PDF - 573 KB)
			Olugbenga “Gbenga” Okubadejo, PharmD
			11/10/2021Association for Accessible Medicines GRx+Biosims 2021 (PDF - 959 KB)
			Sally Choe, Ph.D.
			11/9/2021FDA’s Emergency Use Authorization: Lessons Learned from the Past to Guide the Future (PDF - 656 KB)
			Patrizia Cavazzoni, MD
			10/5/2021Advancing Efficient and Inclusive Clinical Trials (PDF - 696 KB)
			Patrizia Cavazzoni, MD
			10/4/20212021 PDA/FDA Joint Regulatory Conference (PDF - 859 KB)
			Patrizia Cavazzoni, MD
			9/27/2021FDA Role in Regulation of Cannabis Products (PDF - 1.67 MB)
			Douglas C. Throckmorton, MD
			9/16/2021State of CDER 2021 (PDF - 690 KB)
			Patrizia Cavazzoni, MD
			5/20/2021

2020 Presentations

Title
			Presenter(s)
			DateState of CDER 2020 (PDF - 431 KB)
			Patrizia Cavazzoni, MD
			10/8/2020

2019 Presentations

Title
			Presenter(s)
			DateCDER New Drugs Program: 2019 Update (PDF - 1.32MB)
			Khushboo Sharma, MBA, RAC
			12/3/2019Generic Drug Program Update (PDF - 135 KB)
			Sally Choe, PhD
			4/2019New Drugs Regulatory Program Modernization (PDF - 167 KB)
			Janet Woodcock, MD
			4/2019Search for Balance: FDA’s Approach to the Opioids Crisis (PDF - 2 MB)
			Douglas C. Throckmorton, MD
			3/9/2019FDA Role in Regulation of Cannabis Products (PDF - 88 KB)
			Sharon Lindan Mayl, J.D.
			2/2019Ongoing FDA Work Related to Opioid Overdose Prevention (PDF - 1.5 MB)
			Douglas C. Throckmorton, MD
			1/2019

2018 Presentations

Title
			Presenter(s)
			DateSearch for Balance: FDA’s Approach to the Opioids Crisis (PDF - 2 MB)
			Douglas C. Throckmorton, MD
			3/9/2019Federal Efforts to Prevent Drug Shortages An FDA Perspective (PDF - 66 KB)
			Douglas C. Throckmorton, MD
			12/27/2018Charge to the Committee(PDF - 1MB)
			Douglas C. Throckmorton, MD
			12/13/2018Addressing Opioids: The FDA Response to Challenges in Public Health(PDF - 1 MB)
			Douglas C. Throckmorton, MD
			12/12/2018CDER New Drugs Program: 2018 Update (PDF - 977 KB)
			Khushboo Sharma, MBA, RAC
			12/11/2018CDER Office of Surveillance and Epidemiology: 2018 Update (PDF - 2 MB)
			Gerald J. Dal Pan, MD, MHS
			12/11/2018FDA Update on Drug Compounding(PDF - 1 MB)
			Julie Dohm, J.D., Ph.D.
			10/04/2018FDA Center Updates: CDER  (PDF - 409 KB)
			Douglas C. Throckmorton, M.D.
			9/26/2018OGD Update: Welcome to much more than GDUFA II (PDF - 847 KB)
			Kathleen Uhl, M.D.
			9/7/2018FDA Update: 2018 (PDF - 975 KB)
			Douglas C. Throckmorton, M.D.
			5/21/2018FDA Update: 2018 (PDF - 1 MB)
			Douglas C. Throckmorton, M.D.
			5/17/2018Update: Biosimilar Program in the U.S. (PDF - 236 KB)
			Leah Christl, Ph.D.
			4/27/2018Biosimilar Regulatory Policy: Understanding the Landscape and Relevance to Medical Practice (PDF - 584 KB)
			Sue Lim, M.D.
			4/14/2018Biosimilar and Interchangeable Products: The U.S. FDA Perspective (PDF - 313 KB)
			Joe Franklin, J.D., Ph.D.
			4/14/2018FDA's Actions to Address the Opioid Epidemic (PDF - 1MB)
			Douglas C. Throckmorton, M.D.
			3/14/2018The Role of Social Science in Prescription Drug Promotion at FDA and Preview of Upcoming Studies (PDF - 282 KB)
			Kathryn J. Aikin, Ph.D.
			3/9/20182017 Presentations

Title
			Presenter(s)
			DateCenter for Drug Evaluation and Research - Compliance Central with FDA Center Compliance Directors: Part 1
			(PDF -  810 KB)
			Donald D. Ashley, JD
			12/6/2017CDER Update (PDF - 88 KB)
			Janet Woodcock, MD
			12/5/2017CDER Office of Surveillance and Epidemiology: 2017 Update (PDF - 3.6 MB)
			Gerald J. Dal Pan, MD, MHS
			12/5/2017CDER New Drugs Program: 2017 Update (PDF - 543 KB)
			Patrick Frey
			12/5/2017FDA's Role in Confronting the Opioid Epidemic (PDF - 1 MB)
			Douglas C. Throckmorton, M.D.
			11/14/2017State of OGD: Pivoting to GDUFA II (PDF - 1 MB)
			Kathleen Uhl, M.D.
			11/6/2017FDA's Role in Confronting the Opioid Epidemic (PDF - 823 KB)
			Douglas C. Throckmorton, M.D.
			10/12/2017FDA's Role in Confronting the Opioid Epidemic (PDF - 818 KB)
			Douglas C. Throckmorton, M.D.
			9/18/2017The Collaborative for Effective Prescription Opioids quarterly meeting on September 12, 2017 (PDF - 336 KB)
			Douglas C. Throckmorton, M.D.
			9/12/2017FDA Role in Marijuana Regulation (PDF - 851 KB)
			Douglas C. Throckmorton, M.D.
			7/19/2017Current Expectations and Guidance, Including Data Integrity and Compliance with CGMP (PDF - 796 KB)
			Sarah Barkow and Karen Takahashi
			3/30/2017The Public Health Role of Drug Regulation in the US (PDF - 1 MB)
			Douglas C. Throckmorton, M.D.
			3/20/2017FDA Perspective on Abuse-Deterrent Opioid Development (PDF - 1 MB)
			Douglas C. Throckmorton, M.D.
			3/7-8/2017Bridging Justifications: Supporting the Safety of Excipients in Generic Drug Products (PDF - 495 KB)
			Robert T. Dorsam, Ph.D.
			2/27/2017Compliance Trends (PDF - 725 KB)
			Paula Katz
			2/24/2017Future of Drug Development (PDF - 380 KB)
			Janet Woodcock, M.D.
			2/16/2017CDER 2016 Update for Rare Diseases (PDF - 546 KB)
			Richard Moscicki, M.D.
			2/16/2017FDA 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 theFDA Archive
	2012-2015 Presentations have been archived. To view them, please see the FDA Archive.

Resources For You

Meetings, Conferences, & Workshops (Drugs)

                                                                                  Content current as of:
      10/19/2023
              
              
Regulated Product(s)
		 DrugsCenter for Drug Evaluation and Research | CDER

          
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER
 
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