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.

2016 Presentations

Biosimilars in the US: Progress and Promise (PDF - 268KB)John K. Jenkins, M.D.10/27/2016
Regulatory Flexibility and Lessons Learned: Drugs for Rare Diseases (PDF - 397KB)John K. Jenkins, M.D.10/18/2016
Managing Risk to Quality: the Good and the Bad (PDF - 1.7MB)David Jaworski6/7/2016
The Importance of Assuring Quality Throughout the Lifecycle (PDF - 1.52MB)Richard Friedman, M.S.6/6/2016
Current Expectations and Guidance, including Data Integrity and Compliance with CGMP (PDF -  445KB)Sarah Barkow, PhD6/5/2016
Overview of the Over-the-Counter Drug Monograph Process (PDF - 1.53 MB)Karen Murry Mahoney, MD6/10/2016
Setting the Stage: Current Access Policy Challenges and Initiatives (PDF - 839 KB)Douglas C. Throckmorton, MD6/9/2016
Clinical Implications of Drug Shortages: FDA Perspective (PDF - 507 KB)Douglas C. Throckmorton, MD6/6/2016
FDA Update 2016 - CHPA 2016 Scientific, Regulatory and Quality Conference (PDF - 380KB)Douglas C. Throckmorton, M.D.5/19/2016
Expanded Access to Investigational Drugs and Biologics (PDF - 1.22MB)Richard Klein5/16/2016
Expanded Access Programs for Drugs and Biologics (PDF - 61KB)Richard Moscicki, M.D.5/16/2016
FDA Policies and Actions Related to the Development and Use of Opioids to Treat Pain (PDF - 531 KB)Douglas C. Throckmorton MD5/12/2016
FDA Regulation of Marijuana: Past Actions, Future Plans (PDF - 1.2MB)Douglas C. Throckmorton, M.D.4/12/2016
Presentations from the Office of Manufacturing QualityTwo Presenters3/2016
Office of Generic Drugs Director's Update (PDF - 1.1MB)Kathleen Uhl, M.D.2/24/2016
Title I Implementation - Pharmacy Compounding in 2016 (PDF - 84KB)Jane A. Axelrad2/23/2016

2015 Presentations

Office of Generic Drugs Director's Update: Reaping the Benefits of GDUFA (PDF - 1.1MB)Kathleen Uhl, M.D.12/14/2015
CDER 2016 Priorities (PDF - 115KB)Janet Woodcock, M.D.12/14/2015
CDER New Drug Review: 2015 Update (PDF - 1.3MB)John K. Jenkins, M.D.12/14/2015
New Requirement for Electronic Submission of DMFs (PDF - 1MB)Ginny Hussong11/4/2015
Dispute Resolution with CDER Options and Considerations (PDF - 480KB)Virginia L. Behr10/27/2015
CDER Formal Dispute Resolution: Appeals Above the Division Level (PDF - 491KB)Khushboo Sharma10/27/2015
FDA Perspective on Development of Abuse Deterrent Opioids: Have They Made Difference? (PDF - 382KB)Douglas C. Throckmorton, M.D.10/22/2015
Regulator-HTA-Funder Collaborations: Generic Market Forces in USA (PDF - 1.4MB)Douglas C. Throckmorton, M.D.9/9/2015
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

 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
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)

Use of Targeting in Drug Development
(PDF  - 1MB)

Douglas Throckmorton, MD

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


Life with GDUFA
(PDF - 983KB)

Kathleen Uhl


Robert Lionberger


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

Dave Skanchy, Ph.D.


Susan Rosencrance, Ph.D.


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


Huyi Zhang, Ph.D.


Haitao Li, Ph.D.


Ramnarayan Randad


Douglas W. Stearn


Deborah Johnson, Ph.D.


Russell Wesdyk


Wei Song, Ph.D.

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


Monica Bali

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


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

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.

ASCPT Annual Meeting Open Forum 
(PDF - 1.4MB)

Christine M. V. Moore, Ph.D.

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


Page Last Updated: 10/27/2016
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