FDA Presentations and Publications

Our collection of FDA Presentations and Publications is collected from the FDA web site. Our listing is organized into a single table and is listed by date. Clicking the Title will take you to the .pdf file. To save a copy of the document for yourself, click on the link with your right mouse button (Windows, OS/2, Linux, and Solaris) or click and hold the single mouse button (Mac) to display the context menu. Select "Save Link As...", select the appropriate location (folder) and press "Save." You can find current FDA presentations and publications on the FDA web site.

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Date
(most recent first)		 Title of Presentation or Publication Author(s)

November 10, 2006

Celica Witten, Ph.D., M.D.
Director OCTGT

November 10, 2006

Regulatory Perspectives on Combination Therapy for Cancer

Steven Hirschfeld, MD PhD.

October 23, 2006

Human Cells, Tissues, and Cellular and Tissue Based Products - Selected Regulatory Issues for Tissue Banking in the Hospital

Ellen Lazarus, MD, FCAP

October 23, 2006

Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products Division of Human Tissues Update

Ellen Lazarus, MD, FCAP
October 23, 2006
Jackie Neidinger, BS, CTBS
September 27, 2006
Mary A. Foulkes, Ph.D.
September 27, 2006
Celia Witten, Ph.D., M.D.
September 27, 2006
Brent McCright, Ph.D.
September 27, 2006
Jennifer Catalano
September 27, 2006
Steven Hirschfeld, MD, Ph.D.
September 27, 2006
Ellen Lazarus, M.D.
September 27, 2006
James Crim
September 27, 2006
Celia M. Witten, Ph.D., M.D.
September 27, 2006
Ellen Lazarus, M.D.
September 27, 2006
Donald W. Fink, Jr., Ph.D.
September 27, 2006
Melissa A. Greenwald, M.D.
September 12, 2006
Chris Joneckis, Ph.D.
September 12, 2006
Laura M. St. Martin, M.D., M.P.H.
August 28, 2006
Chris Joneckis, Ph.D,
August 28, 2006
Chris Joneckis, Ph.D.
July 29, 2006
Raj K. Puri, Ph.D., M.D.
July 20, 2006
Chris Joneckis, Ph.D.
June 18, 2006
Siba Bhattacharyya, Ph.D.
June 7, 2006
Celia Witten, Ph.D., M.D.
June 7, 2006
Martha A. Wells, MPH
May 17, 2006
Patricia Holobaugh
May 17, 2006
Patricia Holobaugh
May 18, 2006
Jesse L. Goodman, M.D., MPH
10/23-24/2003

Workshop on Counter Terrorism Products Regulated by the Center for Biologics Evaluation and Research: Effective Strategies to Assist in Product Development

Fast-Tracking Biodefense Vaccines and Therapeutics: An Urgent Challenge We Must Meet Jesse L. Goodman, MD, MPH
Submitting the IND: An Overview Donna Chandler, Ph.D.
Perspective on the "Animal Rule" Karen L. Goldenthal, M.D.
Non-Clinical Safety Assessment of Vaccines Marion F. Gruber, Ph.D.
Preclinical Evaluation of Cellular and Gene Therapy Products Mercedes A. Serabian, M.S., DABT
Clinical Development - Counter Terrorism Vaccines Jeff Brady, M.D., M.P.H.
OBRR Perspective on Clinical Development Phase L. Ross Pierce, M.D.
A Regulatory Perspective on the Development of New Vaccines Against Bacillus anthracis and Lessons Learned Thus Far Julianne C.M. Clifford, Ph.D.
Steven R. Bauer, Ph.D.
Development of West Nile virus Testing and Donor screening as a Model for Screening Bioterrorist Agents Hira Nakhasi, Ph.D.
Product Development and Manufacturing John Finkbohner, Ph.D.
Counter terrorism-related Specific Immune Globulins: Problems and Challenges in Development Dorothy Scott, M.D
Product Development for Preventive Vaccines Michael Merchlinsky
Steven R. Bauer, Ph.D.
The Biologics License Application Process Robert A. Yetter, Ph.D.
Select Agents in Product Development M. Christine Anderson
Kimberly A. Cressotti
Select Legal Issues, Including Informed Consent Mark Raza
9/11 - 12/2003

FDLI Conference

8/25 - 27/2003

8th Annual GMP by the Sea

CBER Compliance Activities: Looking Forward James S. Cohen, J.D.
The Future Look of CBER Mark A. Elengold
CBER/CDER Consolidation Mark A. Elengold
6/23-25/2003

BIO 2003

CBER CDER Transition Robert A. Yetter, Ph.D.
Approval Process - Overview and Oversight Robert A. Yetter, Ph.D.
E-Sub Update (Presentation is split into 8 sections) Michael B. Fauntleroy

Part 1

Part 2

Part 3

Part 4

Part 5

Part 6

Part 7

Part 8
6/16/2003

DIA Annual Meeting / Risk Management for Biological Products

How CBER is Using Risk Analysis to Inform Decision-making Steve Anderson, Ph.D., M.P.P
Post-marketing Risk Assessment and Management of Biologic Products Robert Ball, MD, MPH, ScM
Risk Management in Biologics: Special Considerations and Recent Vignettes Jesse L. Goodman, M.D., M.P.H
6/4-5/2003

6th Annual FDA/OCRA Educational Conference

CBER Hot Topics Mark A. Elengold
E-Sub Update Mark A. Elengold
Risk Based Compliance Initiatives Mark A. Elengold
6/4/2003
4/28/2003
4/21/2003
4/2003

ISPE Meeting

11/4-5/02

Workshop on Development of Donor Screening Assays for West Nile Virus

November 4th, 2002

November 5th, 2002
4/23/2002
11/27/2001

FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting

Part 1

Part 2

5/8/2000
PhRMA 2000 Scientific and Regulatory Affairs Section Meeting

How will FDA Meet the Challenges of New Technologies?
Phil Noguchi, M.D. 0a

5/2/2000
Third Annual Conference on Vaccine Research

Vaccines and Immune Mediated Diseases
Frederick Miller, M.D., Ph.D. 0a0

3/31/2000
PhRMA/FDA  Workshop; Error & Accident Reporting

FDA Adverse Event Reporting Systems
Frederick Varricchio, M.D., Ph.D.
Error & Accident Reporting
Sharon O'Callaghan
Error & Accident Reporting
Marsha W. Major 0aa0

4/13/99
PDA Symposium

FDA Current Perspective on Contract, Divided and Shared Manufacturing
Rebecca A. Devine, Ph.D., Associate Director for Policy, CBER
Team Biologics
Rebecca A. Devine, Ph.D., Associate Director for Policy, CBER
2/1/99

DIA Biotechnology Workshop;

The Regulation of Biotechnology: Product Development for the New Millennium Kathryn C. Zoon, Ph.D.; Director, CBER
Expanded Access Karen Weiss, M.D.
Effective use of the Historical Control Trial Karen Weiss, M.D.
1/12/99

FDA Electronic Workshop; Electronic Records and Electronic Signatures Title 21 CFR Part 11

Answers to Frequently Asked Questions Paul J. Motise, Consumer Safety Officer/ Division of Manufacturing and Product Qualtiy
Computer Validation Janis V. Halvorsen/ Division of Manufacturing and Product Quality
Part 11 and FDA Inspections Christine Nelson/ Office of Compliance
10/26/98
10/5/98

PDA/FDA Joint Conference

FDA Modernization Act - A CBER Perspective
Kathryn C. Zoon, PhD/ Director, CBER
10/5/98

PDA/FDA Joint Conference

Comparability Protocols, Manufacturing Changes, and CMC Issues Rebecca A. Devine, PhD/ Associate Director for Policy
CBER Manufacturing Changes Rebecca A. Devine, PhD/ Associate Director for Policy
9/2/98

Biological Products Regulated Under Section 351 of the Public Health Service Act; Open Public Meeting


Kathryn C. Zoon, Ph.D./ Director, CBER
Rebecca A. Devine, Ph.D./ Associate Director for Policy
Robert A. Yetter, Ph.D./Special Assistant to the Associate Director for Policy

    
7/14/98

FDLI: Biologics Update ‘98

Kathryn C. Zoon, Ph.D./ Director, CBER  
Submission of Chemistry, Manufacturing, and Controls Information to the IND Robert A. Yetter, Ph.D./ Special Assistant to the Associate Director for Policy
The New Biologics Approval Process Rebecca A. Devine, Ph.D./ Associate Director for Policy
6/16/98

Bio ‘98


Changes in Biological Product Regulation
Rebecca A. Devine, Ph.D./ Associate Director for Policy
5/22/98

Workshop on Electronic Submissions of Biologics


eCRFs/eCRTs and the eBLA, ePLA/ELA
Mary A. Buesing, M.D.
5/22/98

Workshop on Electronic Submissions of Biologics


Electronic Lot Release Protocol - eLRP
Deborah J. Parshall/ Director, Product Release Branch
4/22/98

Biotech ‘98: From Promise to Reality


Insight into the New FDA Kathryn C. Zoon, Ph.D./Director, CBER
3/4/98

FDA Modernization Act of 1997 Workshop

“I’m From the FDA and I’m Here to Help You and Me”
Kathryn C. Zoon, Ph.D./Director, CBER

 
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