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Meetings, Conferences, & Workshops (Drugs)

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.

2013 Presentations

Presentation(s)	Title	Presenter(s)	Date
	View from a Regulator: Clinical CAPAs and Their Role in Your Overall Compliance Model	Jean Mulinde, M.D.	1/28/2013

2012 Presentations

Title	Presenter(s)	Date
CDER New Drug Review: 2012 Update	John K. Jenkins, M.D.	12/10/2012
CDER Priorities 2012	Douglas C. Throckmorton, M.D.	12/10/2012
Update from the Office of Surveillance and Epidemiology	Gerald J. Dal Pan, M.D., MHS	12/10/2012
Biosimilar User Fee Act of 2012 (BsUFA): Requirements and Implementation	Leah Christi, Ph.D.	2012
Benefit-Risk Considerations in CDER: Development of a Qualitative Framework	Patrick Frey	6/28
Society for Nuclear Medicine Annual Meeting (RDRC Program)	13 Presenters	6/9-13/2012
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 Workshop	Multiple Presenters	5/30-31/2012
Emerging Regulatory Changes in Post-Approval Safety and Risk Management (PDF - 1MB)	Gerald J. Dal Pan, M.D., MHS	5/1/2012
Context of Use for Clinical Outcome Assessments (PDF - 460KB)	Robert Temple, MD	4/25/2012
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 Presentations	11 Presenters	4/12/2012
FDA Update (PDF - 2MB)	Ilisa B.G. Bernstein, PharmD, J.D. and Connie T. Jung, RPh, PhD	3/11/2012
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 Presenters	2012
Office of Scientific Investigations Metrics Overview	Office of Scientific Investigations	1/2012
CDER Data Standards Presentations	CDER and CBER	1/26/2012
Electronic Submissions Presentations	Multiple Presenters	2012

2011 Presentations (Open/Close)

Title	Presenter(s)	Date
CDER New Drug Review 2011 Update FDA CMS Summit (PDF - 2.7MB)	John Jenkins, M.D.	12/8/2011
ISPE Pharmaceutical Quality Systems (ICHQ10) Conference	Multiple Presenters	11/14/2011- 11/16/2011
Continuing Pharmacy Education (CPE) Update Presentation (PDF - 260KB)	Commander Postelle Birch-Smith and Lieutenant Ashlee Janusziewicz	10/31/2011
CDER Presentations: AAPS Annual Meeting	Multiple Presenters	10/23/2011- 10/27/2011
Public Workshop Presentations: Review and Qualification of Clinical Outcome Assessments	9 Presenters	10/19/2011
Generic Pharmaceutical Association 2011 Fall Technical Conference	Multiple Presenters	10/3/2011- 10/5/2011
CDER Public Workshop Meeting Presentations: Approach to Addressing Drug Shortage	16 Presenters	9/26/2011
Generic Drug User Fees Stakeholder Update	Peter C. Beckerman	8/25/2011
Process Validation A Lifecycle Approach (PDF - 253KB)	Grace E. McNally	5/6/2011
CDER Update University of Georgia GMP Conference (PDF - 389KB)	Richard L. Friedman	3/15/2011- 3/17/2011
Public Meeting Presentations: Positron Emission Tomography (PET)	11 Presenters	3/2/2011
Generic Drug User Fees Stakeholder Update	Peter C. Beckerman	2/23/2011
Public Workshop: Determination of System Attributes for the Tracking and Tracing of Prescription Drugs	Food and Drug Administration	2/15/2011- 2/16/2011
Division of Drug Marketing, Advertising, and Communications (Various Meetings)	Multiple Presenters	2011
Genomics at FDA	Multiple Presenters	2011
Electronic Submissions Presentations (Various Meetings)	Multiple Presenters	2011

2010 Presentations (Open/Close)

Title	Presenter(s)	Date
Update from CDER, FDA/CM meeting	Janet Woodcock, M.D.	12/9/2010
Public Workshop: Safe Use Initiative	Multiple Presenters	11/16/2010- 11/17/2010
Drug Interaction Presentations (Various Meetings)	Multiple Presenters	2010
Guidance for Industry: Animal Models-Essential Elements to Address Efficacy Under the Animal Rule	Multiple Presenters	11/5/2010
Generic Pharmaceutical Association (GPhA)/FDA 2010 Fall Technical Conference	Multiple Presenters	10/20/2010- 10/21/2010
Regional Public Meeting: Preparation for ICH Steering Committee and Expert Working Group Meetings in Fukuoka, Japan	Multiple Presenters	10/13/2010
Public Hearing: Development and Distribution of Patient Medication Information for Prescription Drugs	Multiple Presenters	9/27/2010- 9/28/2010
Public Meeting: Request for Comments Generic Drug User Fee	Multiple Presenters	9/17/2010
The United States Regulator's Decision-Making Context (PDF - 91KB)	Janet Woodcock, M.D.	4/23/2010
The United States Regulator's Perspective on Risk-Benefit Considerations (PDF - 434KB)	John K. Jenkins, M.D.	4/23/2010
Tough Calls: When a Drug Causes Rare and Serious Adverse Effects, But Offers Only Symptomatic Benefits (PDF - 262KB)	Robert J. Temple, M.D.	4/23/2010
4th Annual FDA/DIA Statistics Forum	Multiple Presenters	4/19/2010- 4/21/2010
Genomics at FDA	Multiple Presenters	2010
Electronic Submissions Presentations (Various Meetings)	Multiple Presenters	2010
Division of Drug Marketing, Advertising, and Communications (Various Meetings)	Multiple Presenters	2010

2009 Presentations (Open/Close)

Title	Presenter(s)	Date
New Drug Review: 2009 Update (PDF-513KB)	John K. Jenkins M.D.	12/3/2009
Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools	Multiple Presenters	11/12/2009- 11/132009
CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process	Multiple Presenters	11/15/2009
Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop	Multiple Presenters	4/18/2009
Division of Drug Marketing, Advertising, and Communications (Various Meetings)	Multiple Presenters	2009

2008 Presentations (Open/Close)

Title	Presenter(s)	Date
CDER Priorities for 2009	Janet Woodcock M.D.	12/3/2009
New Drug Review: 2008 Update	John K. Jenkins, M.D.	12/4/2008
Importation of Active Pharmaceutical Ingredient (API) Requirements	Multiple Presenters	7/16/2008
Division of Drug Marketing, Advertising, and Communications (Various Meetings)	Multiple Presenters	2008

2007 Presentations (Open/Close)

Title	Presenter(s)	Date
Public Workshop: FDA/Small Business Administrations Drug Educational Forum	Multiple Presenters	4/25/2007
Marketed Unapproved Drugs Meeting	Multiple Presenters	1/9/2007
Division of Drug Marketing, Advertising, and Communications (Various Meetings)	Multiple Presenters	2007

2006 Presentations (Open/Close)

Title	Presenter(s)	Date
Presentation to the American Public Health Association	Steven K. Galson, M.D., M.P.H	11/6/2006
Center Director's Update, 742nd Annual Meeting of the Drug Information Association Philadelphia, PA	Steven K. Galson, M.D., M.P.H	6/18/2006- 6/22/2006
Division of Medical Imaging and Hematology Products Presentations at the Annual Society of Nuclear Medicine Meeting	Multiple Presenters	6/2006
Cancer Drug Approval Endpoints (Various Meetings)	Multiple Presenters	10/26/2006
Hepatotoxicity Steering Group Meeting Public Workshop on Emerging Clostridial Disease Atlanta, Georgia	Multiple Presenters	5/11/2006
Public Workshop: Small Pharmaceutical Business Educational Forum	Multiple Presenters	4/25/2006
Division of Drug Marketing, Advertising, and Communications (Various Meetings)	Multiple Presenters	2006
Presentations from the Office of Oncology Drug Products	Multiple Presenters	2006

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