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

View PresentationBreakthrough Therapy Designation: An Analysis of the Past Two and a Half Years (PDF - 1MB)Kim Taylor4/24/2015
View PresentationApplying the Breakthrough Criteria: Oncology, Neurology, Anti-Infective/Psychiatry/Hematology (PDF - 2MB)Multiple Presenters4/24/2015
View PresentationCurrent CDER Initiatives (PDF - 768KB)Douglas C. Throckmorton, M.D.4/20/2015
View PresentationFDA Perspective on Assessment of Drugs – Abuse Potential and Abuse Deterrence (PDF - 752KB)Douglas C. Throckmorton, M.D.4/16/2015
View PresentationFDA Work on Medical Products Containing Marijuana (PDF - 518KB)Douglas C. Throckmorton, M.D.3/14/2015
View PresentationCreating The Path to Success with GDUFA (PDF - 1.09MB)Kathleen Uhl, M.D.2/10/2015
View PresentationGDUFA Regulatory Science Update (PDF - 220KB)Robert Lionberger, Ph.D.2/10/2015
View PresentationA US Regulator’s View on Abuse Deterrent Formulations of Opioids (PDF - 55KB)Douglas C. Throckmorton, M.D.2/3/2015
View PresentationOverview of FDA Support for Innovation (PDF - 683KB)Douglas C. Throckmorton, M.D.2/2/2015
View PresentationNon-Clinical Cardiovascular Safety Testing: Moving Forward (PDF - 244KB)Douglas C. Throckmorton, M.D.1/2015
View Presentation Selected FDA Activities on Opioids  (PDF - 512KB)Douglas C. Throckmorton, M.D. 1/7/2015

2014 Presentations

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
Douglas C. Throckmorton, MD10/22/2014
View PresentationHTA-Regulatory Assessments: Dialogue, Linkages, Adaptive Licenses (PDF - 51KB)Douglas C. Throckmorton, MD9/16/2014
View PresentationOffice of Pharmaceutical Quality: Global Drug Development and its Impact on CDER’s Drug Review Process Symposium
(PDF - 996KB)
Robert Iser6/24/2014
View PresentationGlobal Drug Development and its Impact on CDER’s Drug Review Process SymposiumMultiple Presenters 6/23-24/2014
View PresentationWill Government encourage innovation for the development of abuse deterrent formulations?
(PDF - 370KB)
Douglas C. Throckmorton, MD6/25/2014
View PresentationImplementation of Quality by Design  A Regulatory Perspective (PDF - 1MB)Sarah Pope Miksinski6/16/2014
View PresentationsMultiple Presenters6/15-19/2014
View PresentationFDA Response to Drug Shortages
(PDF - 469KB)
Douglas C. Throckmorton, MD6/4/2014
View Presentation  FDA/CDER’s Office of Pharmaceutical Quality (PDF - 262KB)Lucinda Buhse5/14/2014
View PresentationFDA Drug Quality Regulation (PDF - 994KB) Brian Hasselbalch 5/14/2014
View PresentationImpact of Abuse-Deterrent Formulations of Opioids
(PDF - 545KB)
Douglas C. Throckmorton, MD4/21/2014
View PresentationValue of a Qualified Clinical Outcome Measure
(PDF - 426KB)
Douglas C. Throckmorton, MD4/3/2014
View Presentation UPDATE on GDUFA and FDA’s Office of Generic Drugs
(PDF - 1MB)
 Kathleen Uhl, MD2/20/2014
View PresentationFDA Regulation of Controlled Substances
(PDF - 429KB)
Douglas C. Throckmorton, MD2/19/2014
View PresentationFDA Reflections on EMA Joint Regulator/Industry Workshop (PDF - 168KB)Christine Moore1/29/2014
View PresentationQuality Risk Management and Submission Strategies for Breakthrough Therapies (PDF - 806KB)Sarah Pope Miksinski1/22/2014
View Presentations Multiple Presenters1/21-24/2014

2013 Presentations (Open/Close)

View PresentationUse of Targeting in Drug Development
(PDF  - 1MB)

Douglas Throckmorton, MD

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

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

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

Robert Iser

View Presentation

Life with GDUFA
(PDF - 983KB)

Kathleen Uhl

View Presentation

Robert Lionberger

View Presentation

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

Dave Skanchy, Ph.D.

View Presentation

Susan Rosencrance, Ph.D.

View Presentation

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

View Presentation

Huyi Zhang, Ph.D.

View Presentation

Haitao Li, Ph.D.

View Presentation

Ramnarayan Randad

View Presentation

Douglas W. Stearn

View Presentation

Deborah Johnson, Ph.D.

View Presentation

Russell Wesdyk

View Presentation

Wei Song, Ph.D.

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

Multiple Presenters

View Presentation

Monica Bali

View PresentationHow Public-Private Partnerships Benefit All Stakeholders (PDF - 1MB)Douglas C. Throckmorton, M.D.9/10/2013
View PresentationVirginia L. Behr6/24/2013
View PresentationAmy Bertha6/24/2013
View PresentationMultiple Presenters6/23-27/2013
View PresentationMultiple Presenters6/21/2013
View PresentationMultiple Presenters6/19-20/2013
View PresentationMultiple Presenters


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

Challenges of Globalization  
(PDF - 834KB)

Howard R. Sklamberg5/5/2013
View PresentationAdverse 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
View PresentationFDA Perspective: Transformational Initiatives
(PDF - 252KB)
Rachel B. Sherman, M.D., MPH4/30/2013
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 PresentationThe 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 PresentationThe Challenges of Globalization
(PDF - 1.50MB)
Howard R. Sklamberg3/8/2013
View Presentation Clinical Pharmacology and The Turning Tide of Drug Regulation
(PDF - 2.9) 
Issam Zineh, PharmD3/8/2013
View Presentation

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

ShaAvhree Buckman-Garner, M.D., Ph.D.
View Presentation

ASCPT Annual Meeting Open Forum 
(PDF - 1.4MB)

View Presentation
Christine M. V. Moore, Ph.D.
View Presentation

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

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

2012 Presentations (Open/Close)

View PresentationCDER New Drug Review: 2012 UpdateJohn K. Jenkins, M.D.12/10/2012
View PresentationCDER Priorities 2012Douglas C. Throckmorton, M.D.12/10/2012
View PresentationUpdate from the Office of Surveillance and EpidemiologyGerald J. Dal Pan, M.D., MHS12/10/2012
View PresentationSupplement Review Process
(PDF - 279KB)

Paul Schwartz, Ph.D.

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


Page Last Updated: 05/18/2015
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