FDA Links -- CBER

 

1. FluLaval Influenza Virus Vaccine, Package Insert, Approval Letter (Updated: 7/27/2010)
    
2. Fluzone and Fluzone High-Dose Influenza Virus Vaccine, Package Insert, Approval Letter (Updated: 7/27/2010)
    
3. FluMist Influenza Vaccine Live, Intranasal Package Insert, Approval Letters (Updated: 7/27/2010)
    
4. February 22, 2010: Vaccines and Related Biological Products Advisory Committee Transcripts (PDF - 193KB)  (Posted: 7/21/2010)
    
5. Fast Track Designation Request Performance (Updated: 7/13/2010)
    
6. Charter of the Vaccines and Related Biological Products Advisory Committee (Updated: 7/13/2010)
    
7. Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 145KB) (Updated: 7/13/2010)
    
8. Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 889KB) (Updated: 7/13/2010)
    
9. Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 62KB) (Updated: 7/13/2010)
    
10. Vaccine Safety Webinar Presentation (Posted: 7/12/2010)
     
11. July 26-27, 2010: Blood Products Advisory Committee Meeting Waivers for Conflicts of Interest (Posted: 7/9/2010)
     
12. Roster of the Transmissible Spongiform Encephalopathies Advisory Committee Designated Federal Officer updated (Updated: 7/8/2010)
     
13. Webinar on FDA’s Safety Monitoring of Approved Vaccines FDA Basics Webinar Series (Posted: 7/6/2010)
     
14. Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (Updated: 6/29/2010)
     
15. Charter of the Allergenic Products Advisory Committee (Updated: 6/29/2010)
     
16. 7345.848 - Inspection of Biological Drug Products  Compliance Program Guidance Manual (Updated: 6/22/2010)
     
17. International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Posted: 6/17/2010)
     
18. 2010 Biological Device Application Approvals (Updated: 6/17/2010)
     
19. Risk Evaluation and Mitigation Strategy (REMS) Public Meeting (Posted: 6/17/2010)
     
20. Clinical Investigator Status (Biologics)  Clinical Investigator Inspection List (Updated: 6/14/2010)
     
21. Roster of the Cellular, Tissue and Gene Therapies Advisory Committee Curricula Vitae Added (Posted: 6/14/2010)
     
22. Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 165KB) (Updated: 5/14/2010)
     
23. Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 45KB) (Updated: 5/14/2010)
     
24. May 7, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Transcript (PDF - 353KB) (Posted: 6/11/2010)
     
25. Charter of the Transmissible Spongiform Encephalopathies Advisory Committee (Updated: 6/11/2010)
     
26. Complete List of Licensed Products and Establishments (Updated: 6/10/2010)
     
27. Market Withdrawal of GAMMAGARDLIQUID, Immune Globulin Intravenous (Human) (Posted: 6/3/2010)
     
28. Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products (PDF - 248KB) (Posted: 5/27/2010)
     
29. AABB Donor History Questionnaire Documents (Updated forms, Posted: 5/27/2010)
     
30. Information for Health Care Professionals: Anticipated Short Supply of Coral Snake Antivenom (Pfizer Inc. ) (Posted: 5/19/2010)
     
31. Charter of the Transmissible Spongiform Encephalopathies Advisory Committee Renewed charter (Posted: 5/18/2010)
     
32. Update on Rotavirus Vaccine Updates about Rotavirus, PCV, and Rotavirus Vaccines (Posted: 5/14/2010)
     
33. May 7, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Presentations (Posted: 5/13/2010)
     
34. Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 45KB) (Updated: 5/13/2010)
     
35. Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 165KB) (Updated: 5/13/2010)
     
36. Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 880KB) (Updated: 5/13/2010)
     
37. Complete List of Licensed Products and Establishments (Updated: 5/13/2010)
     
38. Drug Master Files for CBER-Regulated Products (Posted: 5/11/2010)
     
39. Vaccines and Related Biological Products Advisory Committee Meeting Background Material Porcine Circovirus and Rotavirus Vaccines (Posted: 5/6/2010)
     
40. May 7, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Draft Agenda (PDF - 17KB) )Posted: 5/5/2010)
     
41. Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) (PDF - 56KB) (Posted: 4/30/2010)
     
42. Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry (PDF - 198KB) (Posted: 4/30/2010)
     
43. List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f) (Posted: 4/29/2010)
     
44. Important Information Regarding Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating (Posted: 4/15/2010)
     
45. Complete List of Licensed Products and Establishments (Updated: 4/13/2010)
     
46. Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 845KB) (Updated: 4/13/2010)
     
47. Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 35KB) (Updated: 4/13/2010)
     
48. Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments (Updated: 4/12/2010)
     
49. Fast Track Designation Request Performance (Updated: 4/12/2010)
     
50. Background on Study Results of U.S. Academic Researchers Update on Rotarix Vaccine (Posted: 4/8/2010)
     
51. Recall of AMICUS Ancillary PL2410 Plastic Storage Container 4R2350 (Posted: 4/7/2010)
     
52. Clinical Investigator Status (Biologics) Quarterly update of Clinical Investigator Inspection List as of 3/11/2010 (Posted: 4/6/2010)
     
53. 2010 Biological License Application Supplement Noteworthy Approvals (Posted: 4/1/2010)
     
54. 2010 Biological Device Application Approvals (Updated: 4/1/2010)
     
55. 2010 Biological License Application Approvals (Updated: 4/1/2010)
     
56. Final Rule - Revision of Organization and Conforming Changes to Regulations (Posted: 4/1/2010)
     
57. Final Rule - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment (Posted: 4/1/2010)
     
58. Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety Public Workshop (Posted: 3/30/2010)
     
59. Quantitative Risk Assessment: Blood Safety and Availability Public Workshop (Posted: 3/30/2010)
     
60. Update on Rotarix Vaccine (Posted: 3/22/2010)