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  FDA Links  

FDA Links -- CDER/CBER Calendar

 

 
  1. Genomics News and Upcoming Events (updated 1/31/2012)
     
  2. Webinar on CGMP for PET Drugs (12/20/2011)
     
  3. Public Workshop Transcripts - Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors (Posted:11/29/2011)
     
  4. Role of Naloxone in Opioid Overdose Fatality Prevention; Request for Comments; Public Workshop, April 12, 2012, FDA White Oak Campus Building 31, 10903 New Hampshire Avenue, Silver Spring, MD. Meeting information (11/17/2011)
     
  5. November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Final Questions for Committee Discussion (Posted:11/16/2011)
     
    6.
  6. Agenda: Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors Public Workshop (PDF - 34KB) (Posted:11/10/2011)
     
  7. Public Workshop: Quarantine Release Errors in Blood Establishments Presentations (Posted:11/1/2011)
     
  8. Public Workshop - The Development and Evaluation of Next-Generation Smallpox Vaccines Transcript (PDF - 1016KB) (Posted: 10/25/2011)
     
    9.
  9. Public Workshop - Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases Relevant to Blood and Blood Products (Posted: 9/15/2011)
     
  10. Public Workshop - Agenda for the Development and Evaluation of Next-Generation Smallpox Vaccines (Posted: 9/14/2011)
     
  11. Biosimilar and Interchangeable Products User Fee Meetings: Public Stakeholder Meeting Minutes, July 29, 2011 (PDF - 58KB (8/22/2011)
     
  12. Public Workshop - Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors (Posted: 8/19/2011)
     
  13. CDER Small Business Assistance Industry Workshop: Clinical Trials and Electronic Submissions (8/18/2011)
     
  14. FDA Electronic Submissions Gateway (ESG) Webinar - August 16, 2011 (8/15/2011)
     
  15. FDA Webinar on Protecting Your Child’s Health Through Safe and Effective Vaccines (Posted: 8/12/2011)
     
  16. Effects of Ischemia Reperfusion Injury on Outcomes in Kidney Transplantation; Public Workshop, September 8-9, 2011, 8777 Georgia Ave., Silver Spring, MD. Meeting information (7/20/2011)
     
  17. Public Workshop - Quarantine Release Errors in Blood Establishments (Posted: 7/18/2011)
     
  18. FDA Clinical Investigator Training Course (Posted 6/29/2011)
     
  19. CDER Forum for International Drug Regulatory Authorities, October 17-21, 2011, College Park, MD.  Meeting information (5/17/2011)
     
  20. Prescription Drug User Fee Act (PDUFA) Meetings  (5/17/2011):
  21. Public Workshop - Study Methodologies for Diagnostics in the Postmarket Setting, May 12, 2011 May 12, 2011; FDA White Oak Campus, Silver Spring, MD, 20903 (Posted: 5/9/2011)
     
  22. NHLBI PACT Workshop: Cell Therapy for Pediatric Diseases: A Growing Frontier September 14-15, 2011; National Library of Medicine, Lister Hill Center Auditorium, National Institutes of Health (Posted 5/5/2011)
     
  23. Prescription Drug User Fee Act (PDUFA) Meetings: FDA-Industry Meeting Minutes, January 31, 2011 (PDF - 83KB) (5/4/2011)
     
  24. April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Briefing Document: Use of Serum Bactericidal Antibody as an Immunological Correlate for Demonstrating Effectiveness of Meningococcal Conjugate Vaccines (Serogroups A, C, Y, W-135) Administered to Children Less Than 2 Years of Age (PDF - 65KB) (Posted: 3/28/2011)
     
  25. April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Briefing Document: Approaches to Licensure of Meningococcal Vaccines for Prevention of Serogroup B Invasive Meningococcal Disease (PDF - 137KB) (Posted: 3/28/2011)
     
  26. Best Practices for the Prevention of Cargo and Warehouse Theft of FDA Regulated Medical Products and Infant Formula, May 13, 2011, Hilton Washington DC, 1750 Rockville Pike, Rockville, MD 20852. Meeting information and registration (Posted: 3/28/2011)
     
    27.
  27. Drug Safety Oversight Board Meeting, February 17, 2011, Public Summary (Posted: 3/17/2011)
     
  28. Prescription Drug User Fee Act (PDUFA) Meetings (Posted: 3/17/2011):
    1. FDA-Industry Meeting Minutes, January 27, 2011 (PDF - 63KB)
    2. FDA-Industry Meeting Minutes, January 24, 2011 (PDF - 80KB)
       
    29.
  29. DIA/FDA Best Practices for Regulatory Information Synthesis of Randomized Trials for Product Safety Evaluation, March 10-11, 2011, Double Tree Hotel and Executive Meeting Center, 8120 Wisconsin Avenue, Bethesda, Maryland 20814. Meeting information and registration (3/3/2011)
     
  30. DIA/FDA Quantitative Structure-activity Relationship (Q)SAR Approaches to Assessing Genotoxic Impurities in Pharmaceuticals, April 7, 2011, Hilton Rockville Hotel, 1750 Rockville Pike, Rockville, Maryland 20852. Meeting information and registration (3/3/2011)
     
  31. Prescription Drug User Fee Act (PDUFA) Meetings (3/3/2011):
    1. FDA-Industry Meeting Minutes, January 25, 2011 (PDF - 60KB)
    2. FDA-Industry Meeting Minutes, January 20, 2011 (PDF - 57KB)
       
    32.
  32. FDA approves Edarbi to treat high blood pressure (2/28/2011)
     
  33. Medication Guides (updated 2/28/2011)
     
    34.
  34. February 25, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Draft Agenda (Posted: 2/16/2011)
     
  35. Generic Drug User Fee Stakeholder Update, February 23, 2011, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 32, Room 1325, Silver Spring, Maryland 20993. Meeting information (2/15/2011)
     
  36. FDA Webinar on Safety of the Blood Supply (Updated: 2/14/2011)
     
  37. Public Workshop: Product Development Program for Interventions in Patients with Severe Bleeding Due to Trauma or Other Causes Transcripts posted (Posted: 2/9/2011)
     
  38. FDA/EMA Two-day workshop on drug-related progressive multifocal leukoencephalopathy (PML), London, July 25-26, 2011. Meeting information (2/4/2011)
     
  39. The 14th US-Japan Cellular and Gene Therapy Conference (2/4/2011)
     
  40. PQRI Workshop Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products (PODP), February 22-23, 2011, Hyatt Regency Bethesda. Meeting information (1/18/2011)
     
  41. Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop  CDER Workshop (Posted: 1/10/2010)
     
  42. CDER Forum for International Drug Regulatory Authorities, April 4-8, 2011, College Park, MD (1/7/2011)
     
  43. FDA/Drug Information Association (DIA) Statistics Forum, April 11-13, 2011, Bethesda North Marriott, 5701 Marinelli Road, Bethesda, MD 20852. Meeting Information (12/22/2010)
     
  44. DIA/FDA CDER/CBER Computational Science Annual Meeting (Posted: 12/14/2010)
     
  45. DIA/FDA CDER/CBER Computational Science Annual Meeting. March 14-15, 2011, Sheraton National Hotel, Arlington, VA. Meeting Information (11/18/2010)
     
  46. Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations  Presentations added (Updated: 11/15/2010)
     
  47. PQRI-FDA Workshop on Process Drift: Detection, Measurement, and Control in the Manufacture of Pharmaceuticals, December 1-3, 2010, Bethesda North Marriott, 5701 Marinelli Road, Bethesda, MD 20852. Meeting Information (11/3/2010)
     
  48. Division of Drug Information (DDI) Webinar - Drug Information Resources - October 27, 2010
    49. (10/26/2010)
     
  49. Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products – A Public Workshop (updated with agenda, speaker and attendee list, and disclosure forms) (10/25/2010)
     
  50. Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting (10/4/2010)
     
  51. Safe Use Initiative; Public Workshop, November 16-17, 2010, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Room 1503, Silver Spring, Maryland. Meeting information (9/28/2010)
     
  52. Preparation for ICH Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Regional Public Meeting, October 13, 2010, Washington Theater at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852. Meeting Information (9/22/2010)
     
  53. Public Workshop: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products, October 26-27, 2010, Arlington, VA (9/2/2010)
     
  54. 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)
     
  55. 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)
     
  56. 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)
     
  57. 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)
     
  58. 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)
     
  59. Podcast for Healthcare Professionals: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin) (8/4/2010)
     
  60. 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)
     

   

 

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