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

Presentation(s)TitlePresenter(s)Date
Reforming Clinical Trials in Drug Development: Impact of Targeted Therapies (PDF - 502KB)Janet Woodcock, MD11/16/2016
CDER and Research Progress Update on Opioid Action Plan (PDF - 814KB)Douglas C. Throckmorton MD11/15/2016
Implications of Draft Guidelines on Abuse Liability Testing for Generic Opioids (PDF - 613KB)Douglas C. Throckmorton MD11/2/2016
Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products – Framing the Meeting (PDF - 524KB)Douglas C. Throckmorton MD10/31/2016
Biosimilars in the US: Progress and Promise (PDF - 268KB)John K. Jenkins, MD10/27/2016
Office of Generic Drugs Director's Update (PDF - 2MB)Kathleen Uhl, MD10/24/2016
Regulatory Flexibility and Lessons Learned: Drugs for Rare Diseases (PDF - 397KB)John K. Jenkins, MD10/18/2016
NIDA Clinical Trial Endpoints for Cannabis Use Disorder: an FDA View (PDF - 452KB)Douglas C. Throckmorton MD9/12/2016
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, MD5/19/2016
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, MD5/16/2016
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, MD4/12/2016
Presentations from the Office of Manufacturing QualityTwo Presenters3/2016
Office of Generic Drugs Director's Update (PDF - 1.1MB)Kathleen Uhl, MD2/24/2016
Title I Implementation - Pharmacy Compounding in 2016 (PDF - 84KB)Jane A. Axelrad2/23/2016

2015 Presentations

Presentation(s)TitlePresenter(s)Date
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

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

 

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