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  FDA Links  

FDA Links -- CDER Calendar

 

 
  1. Public Workshop: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products, October 26-27, 2010, Arlington, VA (9/2/2010)
     
  2. Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing, September 27-28, 2010, FDA White Oak Campus, Silver Spring, Maryland. Meeting information (8/27/2010)
     
  3. Generic Drug User Fee; Public Meeting; Request for Comments, September 17, 2010, Hilton Washington DC/Rockville and Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852. Meeting information (8/27/2010)
     
    4.
  4. CDER's Small Business Assistance Educational Forum: The Investigational New Drug (IND) Process, October 8, 2010, National Labor College (NLC), George Meany Campus, Silver Spring, MD. (8/9/2010)
     
  5. AAPS Workshop on Advances and Opportunities in Drug Product Manufacturing, September 20 - 21, 2010, Sheraton Inner Harbor Hotel, Baltimore, MD. Meeting information and registration (8/5/2010)
     
  6. Design of Clinical Trials of Aerosolized Antimicrobials for the Treatment of Cystic Fibrosis; Public Workshop, September 23-24, 2010, Crowne Plaza Hotel, 8777 Georgia Avenue, Silver Spring, Maryland 20910. Meeting information (8/4/2010)
     
  7. Podcast for Healthcare Professionals: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin) (8/4/2010)
     
  8. Podcast for Healthcare Professionals: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen (8/4/2010)
     
    9.
  9. Risk Evaluation and Mitigation Strategy (REMS) Public Meeting, July 27-28, 2010, archived meeting webcast (7/29/2010)
     
  10. Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development; Public Workshop, August 2-3, 2010. Meeting information (6/30/2010)
     
    11.
  11. Implementation of the Biologics Price Competition and Innovation Act of 2009 (6/22/2010)
     
  12. Termination of Declarations of Emergency Justifying Emergency Use Authorization (EUA) of Certain Antiviral Drugs—Zanamivir, Oseltamivir Phosphate, and Peramivir (PDF - 31KB) (6/22/2010)
     
  13. CDER Key Officials List (PDF - 113KB) (6/22/2010)
     
    14.
  14. Development of Articles for Rare Diseases, FDA White Oak Campus, Silver Spring, Maryland, June 29-30, 2010. Meeting information (6/21/2010)
     
  15. Risk Evaluation and Mitigation Strategy (REMS) Public Meeting, July 27-28, 2010, FDA White Oak Campus, Silver Spring, Maryland. Meeting information (6/14/2010)
     
    16.
  16. Antibacterial Resistance and Diagnostic Device and Drug Development Research for Bacterial Diseases; Public Workshop, July 26-27, 2010. Meeting information (6/10/2010)
     
  17. Public Workshop: Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors, June 24-25, 2010, Holiday Inn College Park, 10000 Baltimore Ave., College Park, MD 20740. Meeting information (6/9/2010)
     
  18. Issues in the Development of Medical Products for the Prophylaxis/Treatment of Acute Antibody Mediated Rejection (AMR) in Kidney Transplant Recipients; Public Workshop, June 28-29, 2010. Meeting information (6/8/2010)
     
  19. Risk Evaluation and Mitigation Strategy (REMS) Public Meeting, July 27-28, 2010, FDA Conference Center at White Oak, Silver Spring, Maryland 20993. Meeting information (6/4/2010)
     
    20.
  20. 2010 PDA/FDA Joint Regulatory Conference: The New Paradigm: Quality and Compliance in Merging and Emerging Cultures, September 13-16, 2010, Renaissance Hotel, Washington, D.C. Meeting information and registration (6/1/2010)
     
    21.
  21. Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety Public Workshop (Transcripts Added, Updated: 5/29/2010)
     
  22. FDA/Xavier University Global Outsourcing Conference, June 14-16, 2010, Xavier University, 3800 Victory Parkway, Cincinnati, OH 45207. Meeting information (5/20/2010)
     
  23. FDA-ISPE Collaboration: Pharmaceutical Quality Systems, J.W. Marriott, 1331 Pennsylvania Avenue, Washington, D.C. 20004, June 9-10, 2010. Meeting information and registration (5/4/2010)
     
  24. International Conference of Harmonisation Regional Public Meeting, Public Meeting, Wednesday, May 5, 2010, Rockville, Maryland. Meeting information (updated 4/28/2010)
     
  25. Prescription Drug User Fee Act (PDUFA) Webinar (developed to inform stakeholders about the PDUFA program) (4/7/2010)
     
    26.
  26. 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration (Final Program updated 4/5/2010)
     
  27. 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)
     
  28. 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)
     
  29. Public Workshop: Emerging Arboviruses: Evaluating the Threat to Transfusion and Transplantation Safety (Transcripts Added, Updated: 1/22/2010)
     
  30. New CDERLearn Course: Bringing an Unapproved Drug into Compliance (updated 12/18/2009)
     
  31. FDA Orphan Drugs Workshops, February 25-26, 2010, Claremont, CA; August 3-4, 2010, Minneapolis, MN. Meeting Brochure (PDF - 91 KB) (12/10/2009)
     
  32. 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)
     
  33. Public Workshop: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ Safety Dec 14 - 15, 2009 Public Workshop (Posted: 10/27/2009)
     
  34. 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration (10/26/2009)
     
  35. DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010,  Bethesda, MD. Meeting information and registration (10/26/2009)
     
  36. FDA-NCI Workshop on Therapeutic Cancer Vaccines (Meeting location change, Updated: 10/21/2009)
     
  37. Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components (Updated: 10/13/2009)
     
  38. 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)
     
  39. 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)
     
  40. 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)
     
  41. 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)
     
  42. 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)
     
  43. 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)
     
  44. Drug Safety Oversight Board Meeting, Public Summary, June 18, 2009 (7/9/2009)
     
  45. Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry, May 12-13, 2009. Meeting Information (7/7/2009)
     
  46. 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)
     
  47. Agenda for the May 27 - 28, 2009 Opioid REMS Public Meeting (PDF, 5/22/2009)
     
  48. Risk Evaluation and Mitigation Strategies (REMS) and Opioid Analgesics Webinar (4/27/2009)
     
  49. 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)
     
  50. Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry; May 12-13, 2009 (3/26/2009)
     
  51. 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)
     
  52. 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)
     
  53. 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)
     
  54. 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)
     
  55. 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)
     
  56. FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009. Meeting Information and registration (2/9/2009)
     
  57. 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China. Meeting Information and registration (1/27/2009)
     
  58. 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)
     
  59. 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)
       
  60. Drug Safety Oversight Board Meeting, October 16, 2008, Public Summary (10/30/2008) 

    

 

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