About FDA

Meeting Presentations (Drugs)

CDER Presentations Library

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.

2015 Presentations

Presentation(s) Title Presenter(s) Date
View Presentation  Selected FDA Activities on Opioids  (PDF - 512KB) Douglas C. Throckmorton, M.D.  1/7/2015

2014 Presentations

Presentation(s) Title Presenter(s) Date
View Presentation  CDER Priorities (PDF - 138KB) Janet Woodcock M.D.  12/12/2014 
View Presentation   Update From the Office of Surveillance and Epidemiology (PDF - 780KB)  Gerald J. Dal Pan, MD, MHS  12/11/2014 
View Presentation   CDER New Drug Review: 2014 Update (PDF - 1.3MB) John K. Jenkins, M.D.  12/11/2014 
View Presentation Non-clinical Cardiovascular Safety Testing: Moving Forward
(PDF-224KB)
Douglas C. Throckmorton, MD 10/22/2014
View Presentation HTA-Regulatory Assessments: Dialogue, Linkages, Adaptive Licenses (PDF - 51KB) Douglas C. Throckmorton, MD 9/16/2014
View Presentation Office of Pharmaceutical Quality: Global Drug Development and its Impact on CDER’s Drug Review Process Symposium
(PDF - 996KB)
Robert Iser 6/24/2014
View Presentation Global Drug Development and its Impact on CDER’s Drug Review Process Symposium Multiple Presenters  6/23-24/2014
View Presentation Will Government encourage innovation for the development of abuse deterrent formulations?
(PDF - 370KB)
Douglas C. Throckmorton, MD 6/25/2014
View Presentation Implementation of Quality by Design  A Regulatory Perspective (PDF - 1MB) Sarah Pope Miksinski 6/16/2014
View Presentations Multiple Presenters 6/15-19/2014
View Presentation FDA Response to Drug Shortages
(PDF - 469KB)
Douglas C. Throckmorton, MD 6/4/2014
View Presentation   FDA/CDER’s Office of Pharmaceutical Quality (PDF - 262KB) Lucinda Buhse 5/14/2014
View Presentation FDA Drug Quality Regulation (PDF - 994KB)  Brian Hasselbalch  5/14/2014
View Presentation Impact of Abuse-Deterrent Formulations of Opioids
(PDF - 545KB)
Douglas C. Throckmorton, MD 4/21/2014
View Presentation Value of a Qualified Clinical Outcome Measure
(PDF - 426KB)
Douglas C. Throckmorton, MD 4/3/2014
View Presentation  UPDATE on GDUFA and FDA’s Office of Generic Drugs
(PDF - 1MB)
 
 Kathleen Uhl, MD 2/20/2014
View Presentation FDA Regulation of Controlled Substances
(PDF - 429KB)
Douglas C. Throckmorton, MD 2/19/2014
View Presentation FDA Reflections on EMA Joint Regulator/Industry Workshop (PDF - 168KB) Christine Moore 1/29/2014
View Presentation Quality Risk Management and Submission Strategies for Breakthrough Therapies (PDF - 806KB) Sarah Pope Miksinski 1/22/2014
View Presentations  Multiple Presenters 1/21-24/2014

2013 Presentations (Open/Close)

Presentation(s) Title Presenter(s) Date
View Presentation Use of Targeting in Drug Development
(PDF  - 1MB)

Douglas Throckmorton, MD

12/12/2013
View Presentation John K. Jenkins, M.D. 12/11/2013
View Presentation

Priorities for CDER 2013-2014
(PDF - 424KB)

Richard Moscicki, M.D. 12/11/2013
View Presentation Transforming Professional Medical Education
(PDF - 1MB)
 
Douglas C. Throckmorton, MD 12/10/2013
View Presentations Multiple Presenters 11/10-14/2013
View Presentation Successfully Moving Forward with IND and NDA Submissions for Breakthrough Drugs (PDF - 361KB) Sarah Pope Miksinski 11/5/2013
View Presentation Counterfeit Products: The dangers to patients, practitioners
(PDF - 1MB)
 
Howard R. Sklamberg 11/8/2013
View Presentation Future Activity of ICH
(PDF - 566KB)
 
Theresa Mullin, Ph.D. 11/7/2013
View Presentation Impact of PDUFA V from the risk management perspective
(PDF - 106KB)
Gerald J. Dal Pan, MD 11/6/2013
View Presentation Benefit-risk balance assessment during life cycle of medicinal products
(PDF - 473KB)
Gerald J. Dal Pan, MD 11/5/2013
View Presentation

Robert Iser

10/30/2013
View Presentation

Life with GDUFA
(PDF - 983KB)

Kathleen Uhl

10/30/2013
View Presentation

Complex Generic Drugs
(PDF - 331KB)

Robert Lionberger

10/29/2013
View Presentation

Welcome and Introduction – Update on Changes to API Review in OGD
(PDF - 132KB)

Dave Skanchy, Ph.D.

10/28/2013
View Presentation

Susan Rosencrance, Ph.D.

10/28/2013
View Presentation

CDR Kun Shen, Pharm.D., M.S., BCPS

10/2013
View Presentation

Huyi Zhang, Ph.D.

10/28/2013
View Presentation

Haitao Li, Ph.D.

10/28/2013
View Presentation

Ramnarayan Randad

10/28/2013
View Presentation

Compliance and Quality
(PDF - 870KB)

Douglas W. Stearn

10/2013
View Presentation

Deborah Johnson, Ph.D.

10/28/2013
View Presentation

Russell Wesdyk

10/2013
View Presentation

Wei Song, Ph.D.

10/2013
View Presentation Opioid Prescribing Practices and Pain Management: Role of FDA (PDF - 1MB) Douglas C. Throckmorton, M.D. 10/3/2013
View Presentation FDA Perspective on Development of Abuse Deterrent Opioids (PDF - 241KB) Douglas C. Throckmorton, M.D. 10/1/2013
View Presentation

Multiple Presenters

9/25-26/2013
View Presentation

Monica Bali

9/11/2013
View Presentation How Public-Private Partnerships Benefit All Stakeholders (PDF - 1MB) Douglas C. Throckmorton, M.D. 9/10/2013
View Presentation Virginia L. Behr 6/24/2013
View Presentation Amy Bertha 6/24/2013
View Presentation Multiple Presenters 6/23-27/2013
View Presentation Multiple Presenters 6/21/2013
View Presentation Multiple Presenters 6/19-20/2013
View Presentation Multiple Presenters

6/12-13/2013

View Presentation
Coming of Age of Personalized Medicine
(PDF - 797KB)
 
Janet Woodcock, M.D.
 
5/21/2013
View Presentation

Challenges of Globalization  
(PDF - 834KB)

Howard R. Sklamberg 5/5/2013
View Presentation Adverse Event Reporting and Medication Safety Considerations: A View from CDER’s Office of Surveillance and Epidemiology
(PDF - 445KB)
 
Gerald J. Dal Pan, MD, MHS 5/3/2013
View Presentation FDA Perspective: Transformational Initiatives
(PDF - 252KB)
 
Rachel B. Sherman, M.D., MPH 4/30/2013
View Presentation

The Regulatory Pathway for Rare Diseases Lessons Learned from Examples of Clinical Study Designs for Small Populations  
(PDF - 832KB)

Robert J. Temple, M.D. 4/29/2013
View Presentation The Value of A Qualified Outcome Measure
(PDF - 41KB)
 
Janet Woodcock, M.D. 4/1/2013
View Presentation

Drug Induced Liver Injury: Making Decisions, Making Progress
(PDF - 285KB)

Douglas C. Throckmorton M.D. 3/20/2013
View Presentation The Challenges of Globalization
(PDF - 1.50MB)
 
Howard R. Sklamberg 3/8/2013
View Presentation  Clinical Pharmacology and The Turning Tide of Drug Regulation
(PDF - 2.9) 
Issam Zineh, PharmD 3/8/2013
View Presentation

How FDA Promotes Partnerships to Accelerate Medical Product Development 
(PDF - 1.4MB)

ShaAvhree Buckman-Garner, M.D., Ph.D.
 
3/7/2013
View Presentation

ASCPT Annual Meeting Open Forum 
(PDF - 1.4MB)

OCP 3/6/2013
View Presentation
Christine M. V. Moore, Ph.D.
2/25-26/2013
View Presentation

View from a Regulator: Clinical CAPAs and Their Role in Your Overall Compliance Model
 

Jean Mulinde, M.D. 1/28/2013
View Presentation Multiple Presenters 1/23-25/2013

2012 Presentations (Open/Close)

Presentation(s) Title Presenter(s) Date
View Presentation CDER New Drug Review: 2012 Update John K. Jenkins, M.D. 12/10/2012
View Presentation CDER Priorities 2012 Douglas C. Throckmorton, M.D. 12/10/2012
View Presentation Update from the Office of Surveillance and Epidemiology Gerald J. Dal Pan, M.D., MHS 12/10/2012
View Presentation Supplement Review Process
(PDF - 279KB)

Paul Schwartz, Ph.D.

10/13/2012
View Presentation Biosimilar User Fee Act of 2012 (BsUFA): Requirements and Implementation Leah Christi, Ph.D. 2012
View Presentation Benefit-Risk Considerations in CDER: Development of a Qualitative Framework Patrick Frey 6/28
View Presentation Society for Nuclear Medicine Annual Meeting (RDRC Program) 13 Presenters 6/9-13/2012
View Presentation New Drug Review:An Update and a Look Ahead
(PDF - 1MB)
John K. Jenkins, M.D. 6/26/2012
View Presentation Patient-Focused Drug Development
(PDF - 455KB)
Theresa Mullin, Ph.D. 6/20/2012
View Presentation FDA and Opioids: What’s a Regulator to Do?
(PDF - 398KB)
Douglas C. Throckmorton, M.D. 6/14/2012
View Presentation Slides from the May 30-31, 2012 Chronic Pain Workshop Multiple Presenters 5/30-31/2012
View Presentation Emerging Regulatory Changes in Post-Approval Safety and Risk Management
(PDF - 1MB)
Gerald J. Dal Pan, M.D., MHS 5/1/2012
View Presentation Context of Use for Clinical Outcome Assessments
(PDF - 460KB)
Robert Temple, MD 4/25/2012
View Presentation Enrichment Strategies
(PDF - 1MB)
Robert Temple, M.D. 4/25/2012
View Presentation Advances in FDA’s Drug Safety Program
(PDF - 979KB)
Janet Woodcock, M.D. 4/21/2012
View Presentation The Challenges of Implementing Innovations in Drug Development
(PDF - 2MB)
Douglas C. Throckmorton, M.D. 4/18/2012
View Presentation Integrating Patient Preferences into Benefit-Risk Analysis
(PDF - 165KB)
Robert Temple, M.D. 4/17/2012
View Presentation What is the right balance with respect to focusing on CV Safety - Do we have it right?
(PDF - 245KB)
Robert Temple, M.D. 4/17/2012
View Presentation Role of Naloxone in Opioid Overdose Fatality Prevention Presentations 11 Presenters 4/12/2012
View Presentation FDA Update
(PDF - 2MB)
Ilisa B.G. Bernstein, PharmD, J.D. and Connie T. Jung, RPh, PhD 3/11/2012
View Presentation FDA Efforts: Counterfeit Drugs
(PDF - 597KB)
Ilisa B.G. Bernstein, PharmD, J.D. 3/10/2012
View Presentation A Tale of Three UFAs
(PDF - 2MB)
Janet Woodcock M.D.  2/27/2012
View Presentation FDA’s Sentinel Initiative: Current Status and Future Plans
(PDF - 493KB)
Janet Woodcock M.D.  2/27/2012
View Presentation Drug Interaction Presentations
(Various Meetings)
Multiple Presenters 2012
View Presentation Office of Scientific Investigations Metrics Overview Office of Scientific Investigations 1/2012
View Presentation CDER Data Standards Presentations CDER and CBER 1/26/2012
View Presentation Electronic Submissions Presentations Multiple Presenters 2012

 

Page Last Updated: 01/27/2015
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