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 CDER Presentations

[2006] [2005] [2004] [2003] [2002] [2001] [2000] [1999] [1998] [1997] [1996]

Presentations by Steven K. Galson, Former Director of CDER

2008

  1. Importation of Active Pharmaceutical Ingredient (API) Requirements July 16, 2008

2007

  1. FDA/Small Business Administrations Drug Educational Forum; Public Workshop, April 25, 2007
  2. The Transition from Pre-Clinical to Clinical Application of Safety Related Related Genomics, PDFApril, 2007
  3. Marketed Unapproved Drugs Meeting, January 9, 2007

2006

  1. Presentation to the American Public Health Association, PDF November 6, 2006, Steven K. Galson, M.D., M.P.H., CDER Center Director
  2. Steven K. Galson, M.D., M..PH., CDER Center Director, announces changes to the process FDA uses to prioritize the review of generic drug applications. Presentation PDF
  4. 42nd Annual Meeting of the Drug Information Association, June 18-22, 2006, Philadelphia, PA
  5. Division of Medical Imaging and Hematology Products Presentations at the Annual Society of Nuclear Medicine Meeting, June, 2006
  6. Cancer Drug Approval Endpoints (presentations from various meetings)
  7. Division of Drug Marketing, Advertising, and Communications (presentations from various meetings)
  8. Genomics at FDA
  9. Hepatotoxicity Steering Group Meeting
  10. Public Workshop on Emerging Clostridial Disease, May 11, 2006, Atlanta, Georgia
  11. Small Pharmaceutical Business Educational Forum, Public Workshop, April 25, 2006
  12. Presentations from the Office of Oncology Drug Products

2005

  1. 2005 FDA cGMP China Training Program, December 5-7
  2. Genomics at FDA
  3. Public Workshop: Scientific Issues in Assessing the Similarity of Follow-on Protein Products,
    December 12 – 14, 2005
  4. Presentations from the Public Hearing on Direct-to-Consumer Promotion of Medical Products, November 1 and 2, 2005.
  5. Electronic Common Technical Document (eCTD) Tutorial, October 20, 2005
  6. Preparation for International Conference on Harmonization ICH) Meetings in Chicago, Illinois
  7. ECG Warehouse presentations, September 30, 2005
  8. Presentations from the 41st Annual Meeting of the Drug Information Association, June 26-30, 2005, Washington DC
  9. Presentations from the 5/11/2005 Small Business Drug Educational Forum Public Workshop (6/3/2005)
  10. Drug Information Association Presentations, Washington, DC, June 2005
  11. Public Meeting for Levothyroxine Sodium Therapeutic Equivalence, May 23, 2005, Washington, DC
  12. Personalized Medicine: What Is It? How Will It Affect Health Care?, PDF Felix W. Frueh, Ph.D., CDER, 11th Annual FDA Science Forum, April 26, 2005
  13. Electronic Common Technical Document (eCTD) Workshop, Friday, April 22, 2005. Agenda and Presentations
  14. Preparation for International Conference on Harmonization (ICH) Meetings in Brussels, Belgium, April 20, 2005, Rockville, Maryland. Meeting Information and Presentations
  15. Public Hearing: Use of Color on Pharmaceutical Product Labels, Labeling and Packaging. March 7, 2005, Agenda and Presentations
  16. Hepatotoxicity Steering Committee Meeting, February, 2005
  17. Radioactive Drug Research Committee (RDRC) Program

2004

  1. PAT Guidance Workshop at the Royal Pharmaceutical Society, December, 2004, London, U.K. Meeting Presentations
  2. Public Meeting - Radioactive Drugs for Certain Research Uses, November 16, 2004. Presentations
  3. Scientific Considerations Related to Developing Follow-On Protein Products
    Date and Time: Tuesday, September 14, 2004. Meeting Information and Presentations
  4. 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]  
  5. DIA Annual Meeting, 6/2004, Washington, DC.
  6. FDA/NIH Joint Symposium on Diabetes; Final Summary. [Word] or [PDF] (1/4/2005)
  7. Regulatory Review of New Drugs, Carol Cavanaugh, CDER, presented at MLA 2004, Washington, DC, May 24, 2004. [HTML] or [PowerPoint]
  8. "Over the Counter and On the Air: The Advertising of OTC Drug Products," FDA-CHPA Seminar, May 13, 2004. [HTML] or [PowerPoint]
  9. Structured Product Labeling, June 4, 2004
    1. Structured Product Labeling Project for the DailyMed Initiative,  Randy Levin, FDA [HTML] or [PPT]
    2. SPL – An Overview of the Standard, Sandy Boyer, HL7 [HTML] or [PPT]
    3. SPL Challenge, Jeff Poisson, i4i [HTML] or [PPT]
    4. Structured Product Labeling: A View from the Working Group, Kris Spahr, PhRMA, SPL Working Group [HTML] or [PPT]
    5. The Technology of Structured Product Labeling, Robert H. Wallace, PhRMA [HTML] or [PPT]
    6. Technical Perspective for FDA, Steve Gitterman, FDA [PDF]
    7. SPL Challenge, Intrasphere [HTML] or [PPT]
    8. Electronic Label Submission: Structured Product Labeling Tools, Ron Celeste, Mojo [HTML] or [PPT]
    9. SPL Demonstration, First Consulting Group [HTML] or [PPT]
    10. FDA SPL Challenge, Microsoft Corp. [HTML] or [PPT]
    11. SPL Challenge, Mukesh Mehta, Thomson Healthcare [HTML] or [PPT]
    12. Overview: Xpress Author for Microsoft Word, Richard Brandt,  In.vision Research Corporation  [HTML] or [PPT] 

2003

  1. Evaluating Drug Names for Similarities: Methods and Approaches, June 26, 2003
  2. 2003 Annual DIA Meeting, Electronic Regulatory Submissions and Review, June 2003, San Antonio TX   (Posted 7/15/2003)  
  3. DIA Electronic Document Management Meeting, February 13, 2003.   
  4. 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)
  5. 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

2002

  1. IDSA/PhRma/FDA Working Group Meeting November 19-20, 2002
  2. "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.
  3. RAPS 2002 Annual Conference & Exhibition
  4. Drug Information Association, 38th Annual Meeting, 6/2002, Chicago, Illinois (7/15/2002)

2001

  1. Drug Information Association 37th Annual Meeting 2001 Denver, Colorado (8/1/2001)
  2. Drug Information Association Adverse Experience: Postmarketing Surveillance in the New Millennium, January 2001 Meeting (1/26/2001)
  3. Drug Information Association The Use of the Single, Adequate and Well-Controlled Efficacy Study to Support Approval  January 22-23, 2001 (1/29/2001)

2000

  1. Clinical Pharmacology During Pregnancy Addressing Clinical Needs Through Science (1/30/2001)
  2. Drug Information Association Annual Meeting - San Diego, June 2000 (6/22/2000)
  3. EuroMeeting: Drug Information Association, Nice, France, March 9, 2000.   Dr. Lumpkin
  4. Accelerating Drug Development: Regulatory Initiatives in the USA (3/21/2000)
  5. CIOMS V: Pragmatic Approaches to Some Current Challenges in Pharmacovigilance (3/21/2000)
  6. 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

  1. 15th International Conference on Pharmacoepidemiology
    International Society for Pharmacoepidemiology August 28, 1999     (Posted 1/12/2000)
  2. ASHP December 1999: A Medicated Population: The Need for Postmarketing Drug Surveillance, Ralph Lille (Posted 1/5/2000)
  3. Drug Information Association Adverse Event Reporting: From Theory to Practice, February 22-24, 1999
    Washington, DC     (Posted 3/5/99)
  4. Drug Information Association: 35th Annual Meeting, Baltimore, Maryland, July 1999 (Posted 7/02/1999)
  5. Drug Information Association (DIA) Workshop on Electronic Submissions March 1, 1999 (Posted 4/2/1999)

1998

  1. Anti-Infective Drugs Advisory Committee: Guidance to Industry, Developing Antimicrobial Drugs -- General Considerations for Clinical Trials (Posted 8/26/98)
  2. Anti-Infective Drugs Advisory Committee Meeting (65th Meeting) October 15-16, 1998 (Posted 11/6/1998)
  3. Drug Information Association: Annual Meeting, Boston, MA, USA, June 7-11, 1998 (Posted 6/23/1998)
  4. Drug Information Association: Information Technology Initiatives in Drug Registration Submissions - January 12-14, 1998 pdf.gif (146 bytes)(Posted 2/17/1998)
  5. Drug Information Association Workshop: Pediatric Drug Development: Successes and New Solutions - April 20-21, 1998 (Posted 4/29/1998)
  6. FDA/Industry Meeting Presentation by Dr. Gary Chikami: Anti-infectives for Resistant Bacteria Including Selective Spectrum Agents, July 28, 1998 (Posted 8/29/98)
  7. Guidance for Industry: Submissions in Electronic Format, April 30, 1998 (Posted 4/27/1998)
  8. State of the U.S. Drug Regulatory System-August 17, 1998, Janet Woodcock, M.D. (Posted 8/19/98)

1997

  1. AAPS/CRS/FDA Workshop on April 15,1997: ER Guidance by Hank Malinowski (Posted 4/30/1997)
  2. 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)
  3. 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)
  4. Drug Information Association-Montreal: June 1997 (Posted 7/10/1997)
  5. Drug Information Association Workshop: Pharmaceutical Document Management: Moving Beyond Paper in a Global Environment - February 10-12, 1997 (Posted 2/19/1997)
  6. Update on Drug Master File Agency Activities: Art Shaw: May 8, 1997 (Posted 5/14/1997)

1996

  1. CDER/CBER Pharmaceutical Industry Workshop - November 6-7, 1996
  2. FDA and the Internet: Advertising and Promotion of Medical Products (Public Meeting) Minutes and Proceedings

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Date updated: July 16, 2008
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