About FDA

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.

2015 Presentations

Presentation(s)TitlePresenter(s)Date
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 Raggio6/17/2015
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 Taylor4/24/2015
Applying the Breakthrough Criteria: Oncology, Neurology, Anti-Infective/Psychiatry/Hematology (PDF - 2MB)Multiple Presenters4/24/2015
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

2014 Presentations

Presentation(s)TitlePresenter(s)Date
 CDER Priorities (PDF - 138KB)Janet Woodcock M.D. 12/12/2014 
 Update From the Office of Surveillance and Epidemiology (PDF - 780KB) Gerald J. Dal Pan, MD, MHS 12/11/2014 
 CDER New Drug Review: 2014 Update (PDF - 1.3MB)John K. Jenkins, M.D. 12/11/2014 
Non-clinical Cardiovascular Safety Testing: Moving Forward
(PDF-224KB)
Douglas C. Throckmorton, MD10/22/2014
HTA-Regulatory Assessments: Dialogue, Linkages, Adaptive Licenses (PDF - 51KB)Douglas C. Throckmorton, MD9/16/2014
Office of Pharmaceutical Quality: Global Drug Development and its Impact on CDER’s Drug Review Process Symposium
(PDF - 996KB)
Robert Iser6/24/2014
Global Drug Development and its Impact on CDER’s Drug Review Process SymposiumMultiple Presenters 6/23-24/2014
Will Government encourage innovation for the development of abuse deterrent formulations?
(PDF - 370KB)
Douglas C. Throckmorton, MD6/25/2014
Implementation of Quality by Design  A Regulatory Perspective (PDF - 1MB)Sarah Pope Miksinski6/16/2014
Multiple Presenters6/15-19/2014
FDA Response to Drug Shortages
(PDF - 469KB)
Douglas C. Throckmorton, MD6/4/2014
  FDA/CDER’s Office of Pharmaceutical Quality (PDF - 262KB)Lucinda Buhse5/14/2014
FDA Drug Quality Regulation (PDF - 994KB) Brian Hasselbalch 5/14/2014
Impact of Abuse-Deterrent Formulations of Opioids
(PDF - 545KB)
Douglas C. Throckmorton, MD4/21/2014
Value of a Qualified Clinical Outcome Measure
(PDF - 426KB)
Douglas C. Throckmorton, MD4/3/2014
 UPDATE on GDUFA and FDA’s Office of Generic Drugs
(PDF - 1MB)
 
 Kathleen Uhl, MD2/20/2014
FDA Regulation of Controlled Substances
(PDF - 429KB)
Douglas C. Throckmorton, MD2/19/2014
FDA Reflections on EMA Joint Regulator/Industry Workshop (PDF - 168KB)Christine Moore1/29/2014
Quality Risk Management and Submission Strategies for Breakthrough Therapies (PDF - 806KB)Sarah Pope Miksinski1/22/2014
 Multiple Presenters1/21-24/2014

2013 Presentations (Open/Close)

Presentation(s)TitlePresenter(s)Date
Use of Targeting in Drug Development
(PDF  - 1MB)

Douglas Throckmorton, MD

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

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

Richard Moscicki, M.D.12/11/2013
Transforming Professional Medical Education
(PDF - 1MB)
 
Douglas C. Throckmorton, MD12/10/2013
Multiple Presenters11/10-14/2013
Successfully Moving Forward with IND and NDA Submissions for Breakthrough Drugs (PDF - 361KB)Sarah Pope Miksinski11/5/2013
Counterfeit Products: The dangers to patients, practitioners
(PDF - 1MB)
 
Howard R. Sklamberg11/8/2013
Future Activity of ICH
(PDF - 566KB)
 
Theresa Mullin, Ph.D.11/7/2013
Impact of PDUFA V from the risk management perspective
(PDF - 106KB)
Gerald J. Dal Pan, MD11/6/2013
Benefit-risk balance assessment during life cycle of medicinal products
(PDF - 473KB)
Gerald J. Dal Pan, MD11/5/2013

Robert Iser

10/30/2013

Life with GDUFA
(PDF - 983KB)

Kathleen Uhl

10/30/2013

Robert Lionberger

10/29/2013

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

Dave Skanchy, Ph.D.

10/28/2013

Susan Rosencrance, Ph.D.

10/28/2013

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

10/2013

Huyi Zhang, Ph.D.

10/28/2013

Haitao Li, Ph.D.

10/28/2013

Ramnarayan Randad

10/28/2013

Douglas W. Stearn

10/2013

Deborah Johnson, Ph.D.

10/28/2013

Russell Wesdyk

10/2013

Wei Song, Ph.D.

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

Multiple Presenters

9/25-26/2013

Monica Bali

9/11/2013
How Public-Private Partnerships Benefit All Stakeholders (PDF - 1MB)Douglas C. Throckmorton, M.D.9/10/2013
Virginia L. Behr6/24/2013
Amy Bertha6/24/2013
Multiple Presenters6/23-27/2013
Multiple Presenters6/21/2013
Multiple Presenters6/19-20/2013
Multiple Presenters

6/12-13/2013


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

Challenges of Globalization  
(PDF - 834KB)

Howard R. Sklamberg5/5/2013
Adverse Event Reporting and Medication Safety Considerations: A View from CDER’s Office of Surveillance and Epidemiology
(PDF - 445KB)
 
Gerald J. Dal Pan, MD, MHS5/3/2013
FDA Perspective: Transformational Initiatives
(PDF - 252KB)
 
Rachel B. Sherman, M.D., MPH4/30/2013

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
The Value of A Qualified Outcome Measure
(PDF - 41KB)
 
Janet Woodcock, M.D.4/1/2013

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

Douglas C. Throckmorton M.D.3/20/2013
The Challenges of Globalization
(PDF - 1.50MB)
 
Howard R. Sklamberg3/8/2013
 Clinical Pharmacology and The Turning Tide of Drug Regulation
(PDF - 2.9) 
Issam Zineh, PharmD3/8/2013

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

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

ASCPT Annual Meeting Open Forum 
(PDF - 1.4MB)

OCP3/6/2013
Christine M. V. Moore, Ph.D.
2/25-26/2013

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

Jean Mulinde, M.D.1/28/2013
Multiple Presenters1/23-25/2013

2012 Presentations (Open/Close)

Presentation(s)TitlePresenter(s)Date
CDER New Drug Review: 2012 UpdateJohn K. Jenkins, M.D.12/10/2012
CDER Priorities 2012Douglas C. Throckmorton, M.D.12/10/2012
Update from the Office of Surveillance and EpidemiologyGerald J. Dal Pan, M.D., MHS12/10/2012
Supplement Review Process
(PDF - 279KB)

Paul Schwartz, Ph.D.

10/13/2012
Biosimilar User Fee Act of 2012 (BsUFA): Requirements and ImplementationLeah Christi, Ph.D.2012
Benefit-Risk Considerations in CDER: Development of a Qualitative FrameworkPatrick Frey6/28
Society for Nuclear Medicine Annual Meeting (RDRC Program)13 Presenters6/9-13/2012
New Drug Review:An Update and a Look Ahead
(PDF - 1MB)
John K. Jenkins, M.D.6/26/2012
Patient-Focused Drug Development
(PDF - 455KB)
Theresa Mullin, Ph.D.6/20/2012
FDA and Opioids: What’s a Regulator to Do?
(PDF - 398KB)
Douglas C. Throckmorton, M.D.6/14/2012
Slides from the May 30-31, 2012 Chronic Pain WorkshopMultiple Presenters5/30-31/2012
Emerging Regulatory Changes in Post-Approval Safety and Risk Management
(PDF - 1MB)
Gerald J. Dal Pan, M.D., MHS5/1/2012
Context of Use for Clinical Outcome Assessments
(PDF - 460KB)
Robert Temple, MD4/25/2012
Enrichment Strategies
(PDF - 1MB)
Robert Temple, M.D.4/25/2012
Advances in FDA’s Drug Safety Program
(PDF - 979KB)
Janet Woodcock, M.D.4/21/2012
The Challenges of Implementing Innovations in Drug Development
(PDF - 2MB)
Douglas C. Throckmorton, M.D.4/18/2012
Integrating Patient Preferences into Benefit-Risk Analysis
(PDF - 165KB)
Robert Temple, M.D.4/17/2012
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
Role of Naloxone in Opioid Overdose Fatality Prevention Presentations11 Presenters4/12/2012
FDA Update
(PDF - 2MB)
Ilisa B.G. Bernstein, PharmD, J.D. and Connie T. Jung, RPh, PhD3/11/2012
FDA Efforts: Counterfeit Drugs
(PDF - 597KB)
Ilisa B.G. Bernstein, PharmD, J.D.3/10/2012
A Tale of Three UFAs
(PDF - 2MB)
Janet Woodcock M.D. 2/27/2012
FDA’s Sentinel Initiative: Current Status and Future Plans
(PDF - 493KB)
Janet Woodcock M.D. 2/27/2012
Drug Interaction Presentations
(Various Meetings)
Multiple Presenters2012
Office of Scientific Investigations Metrics Overview Office of Scientific Investigations1/2012
CDER Data Standards PresentationsCDER and CBER1/26/2012
Electronic Submissions PresentationsMultiple Presenters2012

 

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