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  FDA Links  

FDA Links -- CDER Calendar

 

 
  1. Drug Safety Oversight Board Meeting, April 17, 2008, Public Summary (5/13/2008)
     
  2. 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)
     
  3. 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)
     
  4. 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)
     
  5. International Conference on Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon, Rockville, MD, April 4, 2008. Meeting Information (4/1/2008)
     
  6. Updated phone number for the FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop (3/17/2008)
     
  7. FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop April 29, 2008. Meeting Information (3/11/2008)
     
  8. Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) Meeting Date: 4/29-30/2008 (Posted 2/8/2008)
     
  9. Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008, Silver Spring, Maryland. Meeting information (12/21/2007)
     
  10. Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop [PDF] (11/28/2007)
     
  11. 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)
     
  12. Use of Medication Guides to Distribute Drug Risk Information to Patients, June, 2007 - Public Meeting Presentations (updated 7/13/2007)
     
  13. Public Meeting on Essential Uses of Ozone Depleting Substances August 2, 2007, Rockville, MD (7/6/2007)
     
  14. Drug Safety Oversight Board Meetings Public Summaries, April 19 (7/3/2007)
     
  15. Use of Medication Guides to Distribute Drug Risk Information to Patients, June, 2007 - Public Meeting Presentations (6/29/2007)
     
  16. Office of Nonprescription Drugs: Chronological List of All NDAC Meetings (1992 to Present) (6/22/2007)
     
  17. Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges (updated 6/12/2007)
    1. Agenda [PDF]
       
  18. Pharmaceutical Quality Systems 2007 - An FDA/Industry Workshop, June 26-27, Parsippany, NJ. Registration and information (5/21/2007)
     
  19. E-08 Product Quality Lifecycle Implementation: Practical Approach to QbD - co-sponsored by the FDA, June 6-7, 2007, Arlington, VA. Meeting Information (4/19/2007)
     
  20. Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients, June 12-13, 2007. Meeting Information (4/9/2007)
     
  21. New Date: International Conference on Harmonization (ICH) Public Meeting Thursday, May 3, 2007, Rockville, MD. Meeting Information (4/4/2007)
     
  22. FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing (Posted: 2/26/2007; Meeting Date: 4/25-26/2007)
     
  23. 1st Annual FDA/DIA Statistics Forum (with FDA presenters), March 5-7, 2007, Doubletree Hotel & Executive Meeting Center, Bethesda, Maryland. Registration and Information (2/20/2007)
     
  24. DIA/FDA Co-Sponsorship Event QT Issues in Drug Development: The Evolving Science, Practical Issues, and Regulatory Implications, April 11-13, 2007, Washington Marriott Hotel, 1221 22nd Street NW, Washington, DC 20037-1294. Meeting Information (2/5/2007)
     
  25. Meeting: FDA/DIA co-sponsored conference: Sharing Knowledge to Improve clinical Drug Development and Regulatory Decisions: Data/models of Diseases, Drugs, Placebo, Baseline, and Dropouts. January 24 and 25, 2007, Washington, DC, Washington Marriott Hotel. Meeting Information [External Site] (1/10/2007)
     
  26. Public Meeting on Supplements and Other Changes to an Approved Application. February 7, 2007, Rockville, MD. Meeting information (1/5/2007)
     
  27. Multiple Myloma Endpoints Meeting, October 26, 2006, Washington, DC. Meeting Information (10/10/2006)
     
  28. Platelet Pheresis Review Checklist: General (Posted: 9/25/2006)
     
  29. Joint FDA/URI Conference - CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control Strategies – A New Paradigm, October 17-18, 2006, Reston, Virginia.  Information [PDF, external site 9/7/2006]
     
  30. International Conference on Harmonization (ICH) Public Meeting, Monday, October 2, 2006, Rockville, MD. Meeting information (8/8/2006)
     
  31. Public Workshop on Emerging Clostridial Disease, May 11, 2006 (6/20/2006)
    1. Summary of Proceedings (PDF)
    2. Meeting Transcript (PDF)
       
  32. CDER Forum for International Regulatory Authorities, September 25 - 28, 2006, Rockville, MD. Program Information and Registration (6/15/2006)
     
  33. 2006 FDA/Industry Workshop: Pharmaceutical Quality Systems, June 23,
    Parsippany, NJ or July 20, Chicago, IL. Program information and Registration [external site] (5/25/2006)
     
  34. Public Workshop on Emerging Clostridial Disease, May 11, 2006. Presentations (5/17/2006)
     
  35. International Conference on Harmonization (ICH) Public Meeting, May 8, 2006, Rockville, MD. Meeting Information (4/24/2006)
     
  36. FDA co-sponsors a hands-on workshop on implementing the Final Rule on the Content and Format of Prescription Drug Labeling. Meeting information [PDF, external site]  (4/4/2006)
     
  37. Creating New Knowledge: FDA & Industry in Dialogue – Wednesday, March 29 in Philadelphia, PA. The sixth conference between the FDA and industry sponsored by Temple University School of Pharmacy. Keynote Speaker: Steven Galson, MD, MPH, Director, CDER. This conference provides participants, industry, and the FDA a forum for dialogue about critical issues affecting drug development. Agenda and Registration. (3/15/2006)
     
  38. Ovarian Cancer Endpoints Public Workshop, April 26, 2006, North Bethesda, Maryland. Meeting Information (PDF, 3/6/2006)
     
  39. Drug Information Association (DIA) Webinar: Physician Labeling Rule, March 21, 2006, 11:00-12:30 EST. Meeting Program (PDF) and Registration [external site] (3/1/2006)
     
  40. Small Pharmaceutical Business Educational Forum Public Workshop, April 25, 2006. (3/1/2006) Meeting Information
     
  41. 2006 FDA cGMP China Training Program, April 24-26, Beijing, China. FDA, Peking University, and ISPE are co-sponsoring a training program to provide the latest updates from the FDA on current regulations and guidances, and interactive training workshops on oral solid dosage, and API manufacturing. Program Information (from the 2005 session) (2/24/2006)
     
  42. SoCRA FDA Clinical Trials Requirements and GCP Conference, Co-sponsored with FDA, May 17 and 18, 2006 in Baltimore, MD. More information and Registration. [External Site] (2/7/2006)
     
  43. APS Workshop on Ensuring the Supply of Qualified Pharmaceutical Scientist Specialists in Product Development and Related Technologies that Meet Current and Future Needs, May 1-2, 2006,  Hyatt Regency Crystal City Arlington, VA Co-Sponsored with FDA.  Program and Registration [external site]
     
  44. AAPS/FDA Third Bioanalytical Workshop: Quantitative Bioanalytical Methods Validation and Implementation - Best Practices for Chromatographic and Ligand Binding Assays, May 1-3, 2006, Hyatt Regency Crystal City Arlington, VA. Program and Registration
    Program and Registration [external site]
     
  45. FDA Public Workshop on Clinical Trial End Points in Primary Brain Tumors, January 20, 2006, 8:00 a.m. to 4:00 p.m. North Bethesda, MD. Meeting information (updated 1/19/2006)
     
  46. Webinar:  CDER Town Meeting: Current Hot Topics Regarding eSubmissions.  January 18, 2006.   Program and Registration [external site]  (1/6/2006)
     
  47. Webinar: The Current Implementation Status of Electronic Case Reporting.  January 19, 2006.   Program and Registration [external site]  (1/6/2006)
     
    48.
  48. FDA Public Workshop on Clinical Trial End Points in Primary Brain Tumors, January 20, 2006, 8:00 a.m. to ~ 5:00 p.m. (TBD), North Bethesda, MD. Meeting Information  [PDF] [Word] (11/22/2005)
     
  49. Follow-on Biologics Workshop: Scientific Issues in Assessing the Similarity of Follow-on Protein Products, New York City, NY, December 12-14, 2005. Meeting Information (11/7/2005)
     
  50. Preparation for International Conference on Harmonization (ICH) Meetings in Chicago, Illinois, Thursday, October 20, 2005, Rockville, Maryland. Meeting information (10/7/2005)
     
  51. Electronic Common Technical Document (eCTD) Tutorial, Thursday, October 20, 2005, Rockville, MD. Information and Registration (10/7/2005)
     
  52. Public Hearing on CDER's Current Risk Communication Strategies for Human Drugs, December 7-8, 2005, National Transportation Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza SW, Washington, DC 20594.(10/3/2005)
     
  53. Application and Validation of Genomic Biomarkers for use in Drug Development and Regulatory Submissions, October 6-7, Bethesda, MD. Co-sponsored by by DIA, FDA, PhRMA, BIO, & PWG.  Agenda and Registration (PDF, 9/22/2005)
     
  54. Public Hearing on Direct-to-Consumer Promotion of Medical Products, November 1 and 2, 2005, National Transportation Safety Board Boardroom and Conference Center, 429 L’Enfant Plaza, SW., Washington, DC 20594.  Public Hearing Information (9/19/2005)
     
  55. SoCRA FDA Clinical Trails Requirements and GCP Conference, Co-sponsored with FDA, December 7 and 8, 2005 in Cincinnati, Ohio. Information and Registration (8/9/2005)
     
  56. Public Meeting for Levothyroxine Sodium Therapeutic Equivalence, May 23, 2005, Washington, DC. (4/22/2005)
     
  57. CDER Live! - Satellite video conference: "CDER's Drug Safety Initiative," May 20, 2005. Video Conference Information and registration (4/22/2005)
     
  58. Viral and TSE Safety Conference, May 16-18, 2005, Bethesda, MD. Co-sponsored by EMEA and FDA. Meeting and registration information (4/18/2005)
     
  59. FDA Drug Educational Forum,  Kansas City, MO, May 11, 2005. This public workshop will provide information about FDA's premarket requirements to drug industry, particularly small businesses, startups, and entrepreneurs. Meeting information and registration (4/13/2005)
     
  60. Free Electronic Common Technical Document (eCTD) Workshop, Friday, 4/22/2005, Rockville, MD. Meeting information (4/11/2005))
     
  61. Drug Quality System - cGMPs for a New Era 2005, co-sponsored workshop by FDA and Consumer Healthcare Products Association, 6/6, or 7/14, or 8/4. Meeting information and registration (4/8/2005)
     
  62. Preparation for International Conference on Harmonization (ICH) Meetings in Brussels, Belgium, April 20, 2005, Rockville, Maryland. Meeting Information (4/8/2005)
     
  63. FDA/DIA Workshop: Critical Path Opportunities - Use of Medical Imaging as a Drug Development Tool, Bethesda, MD, May 5, 2005. Meeting Information and Registration (3/23/2005, PDF)
     
  64. FDA/DIA Workshop:  Pharmacogenomics in Drug Development and Regulatory Decision Making – Workshop 3: Three Years of Promise, Proposals, and Progress on Optimizing the Benefit/Risk of Medicines,  Bethesda, MD, April 11-13, 2005 Meeting information and registration (PDF, 3/16/2005)
     
  65. Drug Educational Forum Public Workshop, May 11, 2005.  Meeting Information and Registration  (2/11/2005)
     
  66. Public Hearing: Use of Color on Pharmaceutical Product Labels, Labeling and Packaging.   March 7, 2005, NIH Campus, Bethesda, MD.  Meeting Information [TXT] [PDF] (2/3/2005)
     
  67. SoCRA FDA Clinical Trails Requirements and GCP Conference, Co-sponsored with FDA, April 13 and 14, 2005 in Philadelphia, Pennsylvania. Information and Registration and Agenda (PDF, 2/1/2005)
     
  68. FDA/DIA Scientific Workshop on Follow-on Protein Pharmaceuticals, February 14-16, 2005, Arlington, VA.  Meeting Information (1/27/2005)
     
  69. Prostate Cancer Endpoints Workshop Summary. Monday morning  Monday afternoon  Tuesday morning (PDF, Posted 1/13/2005)
     
  70. Update on the Study Data Tabulation Model for FDA Submissions Public Meeting, Tuesday, February 1, 2005, Rockville, MD. Meeting Information (1/6/2005)
     
  71. FDA/NIH Joint Symposium on Diabetes; Final Summary. [Word] or [PDF]  (1/5/2005)
     
  72. SoCRA FDA Clinical Trails Requirements and GCP Conference, Co-sponsored with FDA, January 12 and 13, 2005 in San Francisco, Californian. Information and Registration (External Site, 12/2/2004)
     
  73. Public Meeting - Radioactive Drugs for Certain Research Uses. November 16, 2004, Rockville, MD. Meeting Information  Presentations (11/26/2004)
     
  74. CDER Live! - Satellite video conference: Update on FDA's Critical Path Initiative, December 3, 2004, 1:00 pm to 3:30 pm EST.  Co-sponsored by DIA and FDA, this program will be broadcasted from CDRH Television Studio in Gaithersburg, Maryland. Program information and registration. (PDF, 11/24/2004)
     
  75. FDA/ISPE Forum on New PAT Guidance, November 16, 2004, Arlington, VA (international locations also available) Meeting Information (10/18/2004)
     
  76. Public Meeting - Radioactive Drugs for Certain Research Uses. November 16, 2004, Rockville, MD. Meeting Information (10/5/2004)
     
  77. Preparation for International Conference on Harmonization Meetings in Yokohama, Japan October 19, 2004, Rockville, MD. Meeting Information (10/1/2004)
     
  78. DIA First Annual Leadership Conference for Clinical Research Professionals: The Future of Drug Development in a Cost-constrained Environment, 9/20/2004-9/24/2004, Philadelphia PA. Program Co-Chair: David G. Orloff, MD, Director, Division of Metabolic and Endocrine Drug Products, CDER. Program Information and Registration. (8/19/2004)
     
  79. Public Workshop: Scientific Considerations Related to Developing Follow-On Protein Products, September 14-15, 2004.  Federal Register Notice: [TXT] [PDF] (9/10/2004)
     
  80. DIA First Annual Leadership Conference for Clinical Research Professionals: The Future of Drug Development in a Cost-constrained Environment, 9/20/2004-9/24/2004, Philadelphia PA. Program Co-Chair: David G. Orloff, MD, Director, Division of Metabolic and Endocrine Drug Products, CDER. Program Information and Registration. (8/19/2004)
     

 

    

 

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