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[1997] [1996]
- Biopharmaceutics and Drug Product Quality: Performance Tests for Drug
Products, A Look Into the Future, Ajaz S. Hussain, Ph.D. CDER, USP Annual
Scientific Meeting, September, 2004. [PDF]
- DIA Annual Meeting, 6/2004, Washington, DC.
- Regulatory Review of New Drugs, Carol Cavanaugh, CDER, presented at MLA
2004, Washington, DC, May 24, 2004. [HTML]
or [PowerPoint]
- "Over the Counter and On the Air: The Advertising of OTC Drug
Products," FDA-CHPA Seminar, May 13, 2004. [HTML]
or [PowerPoint]
- Structured Product Labeling, June 4, 2004
- Structured Product Labeling Project for the DailyMed Initiative,
Randy Levin, FDA [HTML]
or [PPT]
- SPL – An Overview of the Standard, Sandy Boyer, HL7 [HTML]
or [PPT]
- SPL Challenge, Jeff Poisson, i4i [HTML]
or [PPT]
- Structured Product Labeling: A View from the Working Group, Kris
Spahr, PhRMA, SPL Working Group [HTML]
or [PPT]
- The Technology of Structured Product Labeling, Robert H. Wallace,
PhRMA [HTML]
or [PPT]
- Technical Perspective for FDA, Steve Gitterman, FDA [PDF]
- SPL Challenge, Intrasphere [HTML]
or [PPT]
- Electronic Label Submission: Structured Product Labeling Tools, Ron
Celeste, Mojo [HTML]
or [PPT]
- SPL Demonstration, First Consulting Group [HTML]
or [PPT]
- FDA SPL Challenge, Microsoft Corp. [HTML]
or [PPT]
- SPL Challenge, Mukesh Mehta, Thomson Healthcare [HTML]
or [PPT]
- Overview: Xpress Author for Microsoft Word, Richard Brandt,
In.vision Research Corporation [HTML]
or [PPT]
- 2003 Annual DIA Meeting,
Electronic Regulatory Submissions and Review, June 2003,
San Antonio TX (Posted 7/15/2003)
- DIA Electronic Document Management Meeting, February 13, 2003.
- DIA April 2003 Workshop:
FDA’s Safety Reporting Proposed Rule. Optional Format:
PowerPoint. Audrey A. Thomas, M.S. Office of
Regulatory Policy (Posted 6/23/2003)
- Financial
Assistance and Incentives for Research and Development of New
Drug/Biologic Products, Ron Wilson, Director of Small Business
Assistance, Center for Drug Development and Research, FDA, June 26, 2003
-
IDSA/PhRma/FDA Working Group
Meeting November 19-20, 2002
-
"Bridging What is Known and What is
Not Known" FDA Perspective and Response. Janet
Woodcock, M. D. Director, Center for Drug Evaluation and Research, Food
and Drug Administration, 10/24/2002, National Institutes of Health.
-
RAPS 2002 Annual Conference
& Exhibition
- CDER Executive Staff Briefing: PDUFA III - Risk
Management.
Nancy D. Smith, Ph.D., 10/7/2002.
- Evolving
Perspectives on Managing the Risks of Medical Products, Anne Trontell, M.D., M.P.H., 10/7/2002.
- Postmarketing Risk
Assessment of Drug Products. Julie Beitz, M.D., 10/7/2002.
- Pre-marketing
Drug Risk Assessment, CDER Executive Staff Briefing. Judy Racoosin, M.D., M.P.H., 10/7/2002.
-
Drug Information
Association, 38th Annual Meeting, 6/2002, Chicago, Illinois
(7/15/2002)
-
Drug Information
Association 37th Annual Meeting 2001 Denver, Colorado (8/1/2001)
-
Drug Information
Association Adverse Experience: Postmarketing Surveillance in the New
Millennium, January 2001 Meeting (1/26/2001)
-
Drug Information Association The Use of the Single, Adequate and Well-Controlled Efficacy Study to
Support Approval January 22-23, 2001 (1/29/2001)
Clinical Pharmacology
During Pregnancy Addressing Clinical Needs Through Science
(1/30/2001)
Drug Information Association Annual
Meeting - San Diego, June 2000 (6/22/2000)
EuroMeeting: Drug Information Association, Nice, France, March 9, 2000.
Dr. Lumpkin
-
Accelerating Drug Development: Regulatory
Initiatives in the USA (3/21/2000)
-
CIOMS V: Pragmatic Approaches
to Some Current Challenges in Pharmacovigilance (3/21/2000) -
PhRMA Science & Regulatory Section, Annual
Meeting May 9th, 2000, Session The Future Of Information Management Ralph B.
Lillie - FDAMA Can FDA Achieve a Paperless Environment by 2002?
1999
15th International Conference on
Pharmacoepidemiology
International Society for Pharmacoepidemiology August 28, 1999 (Posted 1/12/2000)
ASHP December 1999: A Medicated
Population: The Need for Postmarketing Drug Surveillance, Ralph Lille (Posted
1/5/2000)
Drug Information Association Adverse Event
Reporting: From Theory to Practice, February 22-24, 1999
Washington, DC (Posted 3/5/99)
Drug Information Association: 35th Annual
Meeting, Baltimore, Maryland, July 1999 (Posted 7/02/1999)
Drug Information Association (DIA)
Workshop on Electronic Submissions March 1, 1999 (Posted 4/2/1999)
Anti-Infective Drugs Advisory
Committee: Guidance to Industry, Developing Antimicrobial Drugs -- General Considerations
for Clinical Trials (Posted 8/26/98)
Anti-Infective Drugs Advisory
Committee Meeting (65th Meeting) October 15-16, 1998 (Posted 11/6/1998)
Drug Information Association: Annual
Meeting, Boston, MA, USA, June 7-11, 1998 (Posted 6/23/1998)
Drug Information Association: Information
Technology Initiatives in Drug Registration Submissions - January 12-14, 1998
(Posted 2/17/1998)
Drug Information
Association Workshop: Pediatric Drug Development: Successes and New Solutions - April
20-21, 1998 (Posted 4/29/1998)
FDA/Industry Meeting
Presentation by Dr. Gary Chikami: Anti-infectives for Resistant Bacteria Including
Selective Spectrum Agents, July 28, 1998 (Posted 8/29/98)
Guidance for Industry: Submissions in
Electronic Format, April 30, 1998 (Posted 4/27/1998)
State of the U.S. Drug Regulatory
System-August 17, 1998, Janet Woodcock, M.D. (Posted 8/19/98)
1997
AAPS/CRS/FDA Workshop on April 15,1997: ER
Guidance by Hank Malinowski (Posted 4/30/1997)
Anti-Infective Drugs Advisory Committee: Guidance To
Industry - Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective
Drug Products Evaluability Criteria For Individual Indications - March 5-7, 1997
(Posted 6/3/97)
Drug Information Association, In Cooperation with
the U.S. Food and Drug Administration and PhRMA: Guidance for Industry: Regulatory
Submissions in Electronic Format Presentations - September 25, 1997 (Updated 11/7/97)
Drug Information Association-Montreal:
June 1997 (Posted 7/10/1997)
Drug Information Association Workshop:
Pharmaceutical Document Management: Moving Beyond Paper in a Global Environment - February
10-12, 1997 (Posted 2/19/1997)
Update on Drug Master File Agency Activities:
Art Shaw: May 8, 1997 (Posted 5/14/1997)
CDER/CBER Pharmaceutical Industry Workshop -
November 6-7, 1996
FDA and the
Internet: Advertising and Promotion of Medical Products (Public Meeting) Minutes and
Proceedings
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