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  FDA Links  

FDA Links -- CDER Calendar

 

 
  1. 2010 PDA/FDA Pharmaceutical Supply Chain Workshop - Enough Talk: Let's Find and Implement Solutions, April 26-28, 2010, Hyatt Regency Bethesda, 7400 Wisconsin Ave, 1 Bethesda Metro Center, Bethesda, MD 20814. Meeting information and registration (3/18/2010)
     
  2. FDA and PAT for Pharma Manufacturing: FDA-Partnering with Industry; a joint FDA/URI College of Pharmacy conference, Bethesda, Maryland, Hyatt Regency Bethesda, May 11-12, 2010. Meeting information and registration (2/26/2010)
     
  3. Public Workshop: Emerging Arboviruses: Evaluating the Threat to Transfusion and Transplantation Safety (Transcripts Added, Updated: 1/22/2010)
     
  4. New CDERLearn Course: Bringing an Unapproved Drug into Compliance (updated 12/18/2009)
     
  5. FDA Orphan Drugs Workshops, February 25-26, 2010, Claremont, CA; August 3-4, 2010, Minneapolis, MN. Meeting Brochure (PDF - 91 KB) (12/10/2009)
     
  6. IABS/FDA co-sponsored Scientific Conference:  Protein Particles and Immunogenicity of Therapeutic Proteins: Filling in the Gaps in Risk Evaluation and Mitigation.  November 12-13, 2009, Bethesda, MD. Meeting and Registration Information (11/10/2009)
     
  7. Public Workshop: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ Safety Dec 14 - 15, 2009 Public Workshop (Posted: 10/27/2009)
     
  8. 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration (10/26/2009)
     
  9. DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010,  Bethesda, MD. Meeting information and registration (10/26/2009)
     
  10. FDA-NCI Workshop on Therapeutic Cancer Vaccines (Meeting location change, Updated: 10/21/2009)
     
  11. Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components (Updated: 10/13/2009)
     
  12. Preparation for ICH meetings in St. Louis, Missouri to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in St. Louis, Missouri, Public Meeting, October 14, 2009, Washington Room, Hilton Rockville, 1750 Rockville Pike, Rockville, Maryland (updated 10/13/2009)
     
  13. DIA/FDA/NCI/PhRMA Progression-Free Survival Oncology Workshop, October 7-9, 2009, DoubleTree Hotel and Executive Meeting Center, 8120 Wisconsin Avenue, Bethesda, Maryland 20814. Meeting information and registration (9/25/2009)
     
  14. DIA/FDA Assessing Benefits and Risks of Medicinal Products in Regulatory Decisions, November 3-5, 2009, Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland. Meeting Information and registration (9/24/2009)
     
  15. DIA/FDA/PhRMA Modeling and Simulation in Drug Development: Quantitative Approaches for Decision Making, October 28-29, 2009, Marriott Bethesda Pooks Hill, 5151 Pooks Hill Road, Bethesda, Maryland. Meeting Information and registration (9/24/2009)
     
  16. Preparation for ICH meetings in St. Louis, Missouri to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in St. Louis, Missouri, Public Meeting, October 14, 2009, Washington Room, Hilton Rockville, 1750 Rockville Pike, Rockville, Maryland (9/14/2009)
     
  17. Drug Information Association (DIA) and Food and Drug Administration (FDA): Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications: Current State of the Art and Opportunities to Advance the Science, September 23-24, 2009, Omni Shoreham Hotel, Washington, DC. Meeting Information and registration (8/20/2009)
     
  18. Drug Safety Oversight Board Meeting, Public Summary, June 18, 2009 (7/9/2009)
     
  19. Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry, May 12-13, 2009. Meeting Information (7/7/2009)
     
  20. Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop, July 29, 2009 and July 30, 2009, Silver Spring, Maryland (6/25/2009)
     
  21. Agenda for the May 27 - 28, 2009 Opioid REMS Public Meeting (PDF, 5/22/2009)
     
  22. Risk Evaluation and Mitigation Strategies (REMS) and Opioid Analgesics Webinar (4/27/2009)
     
  23. Quality Risk Management – Implementation Strategies; U.S. FDA/CDER and University of Rhode Island College of Pharmacy Conference, June 15-16, 2009, Hyatt Regency Bethesda, Bethesda, Maryland. Meeting Information (4/20/2009)
     
  24. Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry; May 12-13, 2009 (3/26/2009)
     
  25. Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland. Public Workshop Information (updated 3/25/2009)
     
  26. 3rd Annual FDA/DIA Statistics Forum: Emerging and Strategic Issues in Drug Development, Personalized Medicine, and a Guidance Update, April 26, 2009, Westin Arlington Gateway, Arlington, VA 22203. Meeting Information (3/13/2009)
     
  27. Drug Information Association (DIA): Cardiovascular Safety, QT, and Arrhythmia Assessment in Drug Development, April 29-May 1, 2009, Hyatt Regency Besthesda, Bethesda, MD. Meeting information (2/23/2009)
     
  28. Forum - Cytokine Therapies: Novel Approaches for Clinical Indications, March 26 and 27, 2009, NYAS Conference Center, New York City, NY. Meeting Information (2/12/2009)
     
  29. PQRI Workshop: Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products, March 9-10, 2009, Hyatt Regency Bethesda, Bethesda, MD. Program and registration (2/11/2009)
     
  30. FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009. Meeting Information and registration (2/9/2009)
     
  31. 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China. Meeting Information and registration (1/27/2009)
     
  32. 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. Meeting Information and registration (1/27/2009)
     
  33. Public Hearing: Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act, December 12, 2008, National Transportation Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594 (Posted: 12/10/2008)
    1. Meeting information
    2. Agenda (PDF)
       
  34. Drug Safety Oversight Board Meeting, October 16, 2008, Public Summary (10/30/2008)
     
  35. International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated 10/17/08)
     
  36. Drug Safety Oversight Board Meeting, September 18, 2008, Public Summary (10/3/2008)
     
  37. Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland: Meeting information and registration (updated 9/29/2008)
     
  38. Drug Development and Drug Interactions: Meetings: FDA Critical Path Transporter Workshop - (updated 9/29/2008)
     
  39. International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated 9/25/2008)
     
  40. Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland: Meeting information and registration (8/22/2008)
     
  41. Drug Safety Oversight Board Meeting, July 17, 2008 (8/21/2008)
     
  42. DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation. October 14, Arlington, VA. Meeting information and registration (7/28/2008)
     
  43. Drug Safety Oversight Board Meeting, June 19, 2008 (7/28/2008)
     
  44. FDA Workshop on Approaches to Reduce Risk of Transfusion Transmitted Babesiosis in the United States (Posted: 7/3/2008; Meeting Date: 9/12/2008)
     
  45. Drug Safety Oversight Board Meeting, April 17, 2008, Public Summary (5/13/2008)
     
  46. DA/ISPE Co-sponsored Event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations (E07), June 4-5, Washington, DC. Meeting information and registration (5/6/2008)
     
  47. Pubic Workshop: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets, Wednesday, May 7, 2008, Silver Spring, MD. Federal Register Notice (5/6/2008)
     
  48. Meeting: A Joint FDA/URI College of Pharmacy Conference – FDA and Generic Drugs: An Interactive Forum, June 30 and July 1, 2008 / Hyatt Regency Bethesda Hotel ~ North Bethesda, MD. Meeting Information [PDF, External Site] (4/2/2008)
     
  49. International Conference on Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon, Rockville, MD, April 4, 2008. Meeting Information (4/1/2008)
     
  50. Updated phone number for the FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop (3/17/2008)
     
  51. FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop April 29, 2008. Meeting Information (3/11/2008)
     
  52. Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) Meeting Date: 4/29-30/2008 (Posted 2/8/2008)
     
  53. Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008, Silver Spring, Maryland. Meeting information (12/21/2007)
     
  54. Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop [PDF] (11/28/2007)
     
  55. CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control Strategies – A Changing Paradigm, October 15-16, 2007 Bethesda North Marriott Hotel & Conference Center. Meeting information (9/10/2007)
     
  56. Use of Medication Guides to Distribute Drug Risk Information to Patients, June, 2007 - Public Meeting Presentations (updated 7/13/2007)
     
  57. Public Meeting on Essential Uses of Ozone Depleting Substances August 2, 2007, Rockville, MD (7/6/2007)
     
  58. Drug Safety Oversight Board Meetings Public Summaries, April 19 (7/3/2007)
     
  59. Use of Medication Guides to Distribute Drug Risk Information to Patients, June, 2007 - Public Meeting Presentations (6/29/2007)
     
  60. Office of Nonprescription Drugs: Chronological List of All NDAC Meetings (1992 to Present) (6/22/2007)

    

 

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