FDA Links -- CBER

 

1. The Role of CBER in the Success against Epidemic Meningitis in Africa - MenAfriVac (PDF - 295KB) (Posted: 1/31/2012)
    
2. Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB) (Posted: 1/18/2012)
    
3. November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Transcript (PDF - 756KB) (Posted:12/22/2011)
    
4. November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Final Public Roster (Posted:12/22/2011)
    
5. November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Final Agenda (PDF - 20KB) (Posted:12/22/2011)
    
6. November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Presentations (Posted:12/22/2011)
    
7. Study Reports Aluminum in Vaccines Poses Extremely Low Risk to Infants Research Summary (Posted:12/21/2011)
    
8. November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Transcript (PDF - 427KB) (Posted:12/19/2011)
    
9. September 22, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Hemacord BLA 125397: Hematopoietic Progenitor Cells, Cord (HPC-C) (PPT - 1.7MB) (Posted:12/14/2011)
    
10. September 22, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Safety Review (PPT - 1.1MB) (Posted:12/14/2011)
     
11. Draft Guidance- Humanitarian Use Device (HUD) Designations (PDF - 79KB) (Posted:12/13/2011)
     
12. Summary Basis for Regulatory Action, December 1, 2011 - Afluria (PDF - 160KB) (Posted:12/12/2011)
     
13. Summary Basis For Regulatory Action, December 1, 2011 - Menactra (PDF - 57KB) (Posted:12/12/2011)
     
14. Presentation: New Drug Review 2011. John Jenkins, M.D., FDA CMS Summit, December 8, 2011. (PDF - 2.7MB) (Posted:12/8/2011)
     
15. Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases (PDF - 57KB) (Posted:12/8/2011)
     
16. October 25, 2011: Allergenic Products Advisory Committee Meeting: Transcript (PDF - 222KB) (Posted:12/8/2011)
     
17. October 25, 2011: Allergenic Products Advisory Committee Meeting: Presentations (Posted:12/7/2011)
     
18. Age and Gender Difference in the Immune System Response to the 2009 H1N1 Pandemic Influenza Virus (PDF - 15.6MB) (12/5/2011)
     
19. Charter of the Vaccines and Related Biological Products Advisory Committee (Updated:11/30/2011)
     
20. QREs: A Subset of Biological Product Deviation Reports (PPT - 286KB) (Posted:11/30/2011)
     
21. Public Workshop Transcripts - Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors (Posted:11/29/2011)
     
22. List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f) (Updated:11/28/2011)
     
23. Direct Recall Classification Program (Blood and Plasma) (Updated: 11/23/2011)
     
24. 13th International Paul-Ehrlich-Seminar - Allergen Products for Diagnosis and Therapy: Regulation and Science Presentations (Posted: 11/18/2011)
     
25. Latest System Changes in the Electronic Biological Product Deviation Reporting (eBPDR) System (Updated: 11/18/2011)
     
26. 2011 Biologics Recalls (Updated:11/17/2011)
     
27. Agenda: Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors Public Workshop (PDF - 34KB) (Posted:11/10/2011)
     
28. Age and Gender Differences Seen in Immune System Response to the 2009 H1N1 Pandemic Influenza Virus (Posted: 11/7/2011)
     
29. Important Product Information – RECOMBINATE [Antihemophilic Factor (Recombinant)] (Posted:11/3/2011)
     
30. Recall of GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] (Posted:11/3/2011)
     
31. September 22, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Transcript (PDF - 430KB) (Posted:11/1/2011)
     
32. List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f) (Updated: 10/28/2011)
     
33. Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (Updated: 10/28/2011)
     
34. SOPP 8420: FDAAA Section 921: Posting of Potential Signals of Serious Risk Effective Date: November 1, 2011 (10/27/2011)
     
35. Public Workshop - The Development and Evaluation of Next-Generation Smallpox Vaccines Transcript (PDF - 1016KB) (Posted: 10/25/2011)
     
36. AABB Abbreviated Donor History Questionnaire Documents (Posted: 10/24/2011)
     
37. FDA Communication on Use of Jet Injectors with Influenza Vaccines (Posted: 10/21/2011)
     
38. Request for Notification for Nominations for a Nonvoting Industry Representative on the Vaccines and Biological Products Advisory Committee (Posted:10/19/2011)
     
39. Biologic Product Shortages Rabies Vaccine RabAvert (Posted:10/19/2011)
     
40. August 1, 2011 Transmissible Spongiform Encephalopathies Advisory Committee Meeting Presentations (10/14/2011)
     
41. Developing the "Ultimate Tool" to Ensure Live Viral Vaccine Safety (PDF - 389KB) Innovation and Regulatory Science Poster (Posted: 10/13/2011)
     
42. Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes (Updated: 10/12/2011)
     
43. Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes (Updated: 10/12/2011)
     
44. 2011 Biological License Application Supplement Noteworthy Approvals (Updated:10/11/2011)
     
45. 2011 Biological Device Application Approvals (Updated:10/11/2011)
     
46. Zostavax (Herpes Zoster Vaccine) Questions and Answers (Updated: 10/3/2011)
     
47. August 1, 2011 Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript (PDF - 312KB) (Posted: 9/27/2011)
     
48. Updated Agenda: The Development and Evaluation of Next-Generation Smallpox Vaccines, September 16, 2011 (PDF - 31KB) (Posted: 9/26/2011)
     
49. Influenza Virus Vaccine for the 2011 - 2012 Season (Updated: 9/21/2011)
     
50. Public Workshop - Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases Relevant to Blood and Blood Products (Posted: 9/15/2011)
     
51. Public Workshop - Agenda for the Development and Evaluation of Next-Generation Smallpox Vaccines (Posted: 9/14/2011)
     
52. Influenza Virus Vaccine for the 2011 - 2012 Season (Updated: 9/13/2011)
     
53. Synonymous (“Silent”) Mutations in Health, Disease, and Personalized Medicine: Review  Innovation and Regulatory Science Research Summary (Posted: 9/9/2011)
     
54. Influenza Virus Vaccine for the 2011 - 2012 Season (Updated: 8/31/2011)
     
55. Public Workshop - Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors (Posted: 8/19/2011)
     
56. FDA Webinar on Protecting Your Child’s Health Through Safe and Effective Vaccines (Posted: 8/12/2011)
     
57. Public Workshop - The Development and Evaluation of Next-Generation Smallpox Vaccines (Updated: 8/11/2011)
     
58. Influenza Virus Vaccine for the 2011 - 2012 Season (Updated: 8/10/2011)
     
59. Identifying Faster Sterility Tests for Biological Products (PDF - 190KB) Innovation and Regulatory Science Poster (Posted: 8/5/2011)
     
60. Public Workshop - Quarantine Release Errors in Blood Establishments (Posted: 7/18/2011)