Internet for Pharmaceutical and Biotech Communities
| Newsletter | Post Jobs | Advertising |
 
 

 

  

Pharm/Biotech Resources

Outsourcing Guide

Cont. Education

Software/Reports

Training Courses

Web Seminars

Jobs

Buyer's Guide

Home Page

Pharm Patents /
Licensing

Pharm News

Federal Register

Pharm Stocks

FDA Links

FDA Warning Letters

FDA Doc/cGMP

Pharm/Biotech Events

Consultants

Advertiser Info

Newsletter Subscription

Web Links

Suggestions

Site Map
 
 
   

 

  FDA Links  

FDA Links -- CDER Calendar

 

 
  1. 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)
     
  2. Agenda for the May 27 - 28, 2009 Opioid REMS Public Meeting (PDF, 5/22/2009)
     
  3. Risk Evaluation and Mitigation Strategies (REMS) and Opioid Analgesics Webinar (4/27/2009)
     
  4. 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)
     
  5. Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry; May 12-13, 2009 (3/26/2009)
     
  6. 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)
     
  7. 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)
     
  8. 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)
     
  9. 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)
     
  10. 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)
     
  11. FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009. Meeting Information and registration (2/9/2009)
     
  12. 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China. Meeting Information and registration (1/27/2009)
     
  13. 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)
     
  14. 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)
       
  15. Drug Safety Oversight Board Meeting, October 16, 2008, Public Summary (10/30/2008)
     
  16. International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated 10/17/08)
     
  17. Drug Safety Oversight Board Meeting, September 18, 2008, Public Summary (10/3/2008)
     
  18. Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland: Meeting information and registration (updated 9/29/2008)
     
  19. Drug Development and Drug Interactions: Meetings: FDA Critical Path Transporter Workshop - (updated 9/29/2008)
     
  20. International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated 9/25/2008)
     
  21. Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland: Meeting information and registration (8/22/2008)
     
  22. Drug Safety Oversight Board Meeting, July 17, 2008 (8/21/2008)
     
  23. DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation. October 14, Arlington, VA. Meeting information and registration (7/28/2008)
     
  24. Drug Safety Oversight Board Meeting, June 19, 2008 (7/28/2008)
     
  25. FDA Workshop on Approaches to Reduce Risk of Transfusion Transmitted Babesiosis in the United States (Posted: 7/3/2008; Meeting Date: 9/12/2008)
     
  26. Drug Safety Oversight Board Meeting, April 17, 2008, Public Summary (5/13/2008)
     
  27. 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)
     
  28. 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)
     
  29. 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)
     
  30. International Conference on Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon, Rockville, MD, April 4, 2008. Meeting Information (4/1/2008)
     
  31. Updated phone number for the FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop (3/17/2008)
     
  32. FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop April 29, 2008. Meeting Information (3/11/2008)
     
  33. Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) Meeting Date: 4/29-30/2008 (Posted 2/8/2008)
     
  34. Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008, Silver Spring, Maryland. Meeting information (12/21/2007)
     
  35. Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop [PDF] (11/28/2007)
     
  36. 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)
     
  37. Use of Medication Guides to Distribute Drug Risk Information to Patients, June, 2007 - Public Meeting Presentations (updated 7/13/2007)
     
  38. Public Meeting on Essential Uses of Ozone Depleting Substances August 2, 2007, Rockville, MD (7/6/2007)
     
  39. Drug Safety Oversight Board Meetings Public Summaries, April 19 (7/3/2007)
     
  40. Use of Medication Guides to Distribute Drug Risk Information to Patients, June, 2007 - Public Meeting Presentations (6/29/2007)
     
  41. Office of Nonprescription Drugs: Chronological List of All NDAC Meetings (1992 to Present) (6/22/2007)
     
  42. Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges (updated 6/12/2007)
    1. Agenda [PDF]
       
  43. Pharmaceutical Quality Systems 2007 - An FDA/Industry Workshop, June 26-27, Parsippany, NJ. Registration and information (5/21/2007)
     
  44. 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)
     
  45. Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients, June 12-13, 2007. Meeting Information (4/9/2007)
     
  46. New Date: International Conference on Harmonization (ICH) Public Meeting Thursday, May 3, 2007, Rockville, MD. Meeting Information (4/4/2007)
     
  47. 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)
     
  48. 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)
     
  49. 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)
     
  50. 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)
     
  51. Public Meeting on Supplements and Other Changes to an Approved Application. February 7, 2007, Rockville, MD. Meeting information (1/5/2007)
     
  52. Multiple Myloma Endpoints Meeting, October 26, 2006, Washington, DC. Meeting Information (10/10/2006)
     
  53. Platelet Pheresis Review Checklist: General (Posted: 9/25/2006)
     
  54. 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]
     
  55. International Conference on Harmonization (ICH) Public Meeting, Monday, October 2, 2006, Rockville, MD. Meeting information (8/8/2006)
     
  56. Public Workshop on Emerging Clostridial Disease, May 11, 2006 (6/20/2006)
    1. Summary of Proceedings (PDF)
    2. Meeting Transcript (PDF)
       
  57. CDER Forum for International Regulatory Authorities, September 25 - 28, 2006, Rockville, MD. Program Information and Registration (6/15/2006)
     
  58. 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)
     
  59. Public Workshop on Emerging Clostridial Disease, May 11, 2006. Presentations (5/17/2006)
     
  60. International Conference on Harmonization (ICH) Public Meeting, May 8, 2006, Rockville, MD. Meeting Information (4/24/2006)
     
  61. 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)
     
  62. 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)
     
  63. Ovarian Cancer Endpoints Public Workshop, April 26, 2006, North Bethesda, Maryland. Meeting Information (PDF, 3/6/2006)
     
  64. 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)
     
  65. Small Pharmaceutical Business Educational Forum Public Workshop, April 25, 2006. (3/1/2006) Meeting Information
     
  66. 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)
     
  67. 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)
     
  68. 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]
     
  69. 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]
     
  70. 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)
     
  71. Webinar:  CDER Town Meeting: Current Hot Topics Regarding eSubmissions.  January 18, 2006.   Program and Registration [external site]  (1/6/2006)
     
  72. Webinar: The Current Implementation Status of Electronic Case Reporting.  January 19, 2006.   Program and Registration [external site]  (1/6/2006)
     
    73.
  73. 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)
     
  74. 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)
     
  75. Preparation for International Conference on Harmonization (ICH) Meetings in Chicago, Illinois, Thursday, October 20, 2005, Rockville, Maryland. Meeting information (10/7/2005)
     
  76. Electronic Common Technical Document (eCTD) Tutorial, Thursday, October 20, 2005, Rockville, MD. Information and Registration (10/7/2005)
     
  77. 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)
     
  78. 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)
     
  79. 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)
     
  80. 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)

     

 

    

 

Hit Counter
     
[ Outsourcing Guide ] [ Cont. Education ] [ Software/Reports ] [ Training Courses ]
[ Web Seminars ] [ Jobs ] [ Consultants ] [ Buyer's Guide ] [ Advertiser Info ]

[ Home ] [ Pharm Patents / Licensing ] [ Pharm News ] [ Federal Register ]
[ Pharm Stocks ] [ FDA Links ] [ FDA Warning Letters ] [ FDA Doc/cGMP ]
[ Pharm/Biotech Events ] [ Newsletter Subscription ] [ Web Links ] [ Suggestions ]
[ Site Map ]