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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.

2014 Presentations

Presentation(s)TitlePresenter(s)Date
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 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

 

2013 Presentations

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

Douglas Throckmorton, MD

12/12/2013
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 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

10/30/2013
View Presentation

Life with GDUFA
(PDF - 983KB)

Kathleen Uhl

10/30/2013
View Presentation

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

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 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

9/25-26/2013
View Presentation

Monica Bali

9/11/2013
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 Presenters6/21/2013
View PresentationMultiple Presenters6/19-20/2013
View PresentationMultiple 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. 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.
 
3/7/2013
View Presentation

ASCPT Annual Meeting Open Forum 
(PDF - 1.4MB)

OCP3/6/2013
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 PresentationMultiple Presenters1/23-25/2013

 

2012 Presentations (Open/Close)

Presentation(s)TitlePresenter(s)Date
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.

10/13/2012
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

 

2011 Presentations (Open/Close)

Presentation(s)TitlePresenter(s)Date
View PresentationCDER New Drug Review 2011 Update
FDA CMS Summit

(PDF - 2.7MB)
John Jenkins, M.D.12/8/2011
View PresentationISPE Pharmaceutical Quality Systems (ICHQ10) ConferenceMultiple Presenters11/14/2011-
11/16/2011
View PresentationContinuing Pharmacy Education (CPE)
Update Presentation
(PDF - 260KB)
Commander Postelle
Birch-Smith and
Lieutenant Ashlee
Janusziewicz

10/31/2011

View PresentationCDER Presentations: AAPS Annual MeetingMultiple Presenters

10/23/2011-

10/27/2011

View Presentation

Public Workshop Presentations:
Review and Qualification of Clinical Outcome Assessments

9 Presenters10/19/2011
View PresentationGeneric Pharmaceutical Association
2011 Fall Technical Conference
Multiple Presenters10/3/2011-
10/5/2011
View Presentation

CDER Public Workshop Meeting Presentations:
Approach to Addressing Drug Shortage

16 Presenters9/26/2011
View Presentation

Generic Drug User Fees Stakeholder Update

Peter C. Beckerman8/25/2011
View PresentationProcess Validation A Lifecycle Approach
(PDF - 253KB)
Grace E. McNally5/6/2011
View Presentation

CDER Update
University of Georgia GMP Conference

(PDF - 389KB)

Richard L. Friedman3/15/2011-
3/17/2011
View Presentation

Public Meeting Presentations:
Positron Emission Tomography (PET)

11 Presenters3/2/2011
View PresentationGeneric Drug User Fees Stakeholder UpdatePeter C. Beckerman2/23/2011
View PresentationPublic Workshop:
Determination of System Attributes for the Tracking and Tracing of Prescription Drugs
Food and Drug Administration2/15/2011-
2/16/2011
View Presentation

Division of Drug Marketing, Advertising, and Communications (Various Meetings)

Multiple Presenters2011
View Presentation

Genomics at FDA

Multiple Presenters2011
ViewIconElectronic Submissions Presentations
(Various Meetings)
Multiple Presenters2011

 

2010 Presentations (Open/Close)

 

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