FDA Links -- CBER

 

1. Pediatric Research Equity Act of 2007 (PREA) (Posted: 5/5/2008)
    
2. 51st Annual FDLI & FDA Conference - 3/26-27/2008 (Posted: 5/5/2008)
   1. Vaccine Safety Team (PDF - 300 KB) - Carmen M. Collazo, PhD
   2. Safety Surveillance for Licensed Biological Products at FDA's Center for Biologics Evaluation & Research (PDF - 206 KB) - Robert P. Wise, MD, MPH
   3. CBER Safety Initiatives: Tissue Safety Team (PDF - 47 KB) - Ruth Solomon, MD
   4. Blood Safety Team (PDF - 26 KB) - Jonathan C. Goldsmith, MD
       
3. Withdrawal of Albumin (Human) 5%, Talecris Biotherapeutics (Posted: 5/1/2008; Withdrawal Date: 4/30/2008)
    
4. Workshop: HL7 SPL Working Group Electronic Drug Registration and Listing Meeting - Webinar (Posted: 4/30/2008, Meeting Date: 5/15/2008)
    
5. Merck Warning Letter- Questions and Answers (Posted: 4/30/2008)
    
6. FEDERAL REGISTER: Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Final Rule (4/29/2008)
    
7. Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update (Posted: 4/28/2008, Updated as of: 4/28/2008)
    
8. Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - Agenda (Posted: 4/23/2008)
    
9. Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 (Posted 4/21/2008)
    
10. Important Product Correction Notification: Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests - Ortho Clinical Diagnostics, Inc (Posted: 4/21/2008, Notification Date: 4/21/2008)
     
11. Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product (Posted 4/17/2008)
     
12. Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests (PDF - 87 KB) (Posted 4/16/2008)
     
13. Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) - Alphabetical List of Registered Establishments - Update (Posted: 4/15/2008)
     
14. Recall of Thymoglobulin - Genzyme Corporation (Posted: 4/10/2008, Recall Date: 4/9/2008)
     
15. Fast Track Designation Request Performance Report - Update (Posted: 4/9/2008)
     
16. Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (PDF - 251 KB) (4/9/2008)
     
17. Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) (PDF - 237 KB) (4/9/2008)
     
18. Fast Track Designation Request Performance Report - Update (Posted: 4/9/2008)
     
19. International Conference on Harmonisation (ICH); Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (4/8/2008)
     
20. FEDERAL REGISTER: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal (4/4/2008)
     
21. Overview of the Regulation of Biological Products (Blood Components and Tissues) - 3/12/2008 (Posted 4/4/2008)
    1. Surveillance and Enforcement (PDF - 88 KB) - Armando Zamora
    2. The Regulation of Biological Products (PDF - 788 KB) - Judy Ciaraldi, Linda S. Mattingly, Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
    3. Regulation of Biological Products - Review (PDF - 711 KB) - Judy Ciaraldi, Linda S. Mattingly, Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
    4. FDA Field Inspections (PDF - 60 KB) - Linda S. Mattingly
    5. FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (PDF - 173 KB) - Laura M. St. Martin, M.D., M.P.H.
        
22. FDA/NIST Sponsored Workshop: In Vitro Analyses of Cell/Scaffold Products - Slide Presentations (Posted: 4/1/2008)
     
23. Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - Updated Meeting Location (Posted: 3/31/2008; Meeting Date: 4/29-30/2008)
     
24. Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007 (Posted: 3/28/2008)
     
25. Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Updated (Posted: 3/27/2008)
     
26. FDA/NIST Sponsored Workshop: In Vitro Analyses of Cell/Scaffold Products - Transcripts (Posted: 3/21/2008)
     
27. HL7 SPL Working Group Electronic Establishment Registration and Drug Listing Follow-up Session - April 2, 2008 (Posted 3/21/2008)
     
28. FDA Approves New Medical Adhesive to Treat Burn Patients (3/20/2008)
     
29. Compliance Program Guidance Manual: 7342.007 - Imported CBER-Regulated Products (Posted: 3/18/2008)
     
30. Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays - Updated (Posted: 3/17/2008)
     
31. Thimerosal in Vaccines - Tables 2 and 3 updated (Posted: 3/14/2008)
     
32. SOPP 8206: Discontinuing Investigational and Related Applications (IRAs) (Posted: 3/13/2008)
     
33. Biological Product Shortage - Digoxin Immune Fab (Ovine) - Updated (Posted: 3/13/2008)
     
34. FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule; Confirmation of Effective Date (Posted 3/7/2008)
     
35. Notification Process for Transfusion Related Fatalities and Donation Related Deaths - Updated (Posted: 3/7/2008)
     
36. Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Years 2005 and 2006 (Posted: 3/7/2008)
     
37. Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (3/7/2008)
     
38. Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (3/7/2008)
     
39. Importing Biological Specimens for Clinical Testing or Research Use Only (FAQs) - Update (Posted: 3/6/2008)
     
40. Licensed Products and Establishments List - Update (Posted: 3/6/2008, Updated through: 2/29/2008)
     
41. Important Safety Information: Dosing and Administration of Immune Globulin (Human), GamaSTAN™ S/D Packaged in 2-ml Syringes (Posted: 3/5/2008)
     
42. Approved Biological NDA and ANDA Applications - Update (Posted: 3/5/2008, Updated through: 2/29/2008)
     
43. Cleared Biological 510(k) Device Applications - Update (Posted: 3/5/2008, Updated through: 2/29/2008)
     
44. Approved Biological Premarket Approval (PMA) Device Applications - Update (Posted: 3/5/2008, Updated through: 2/29/2008)
     
45. Recall of Uni-Gold Recombigen HIV (Posted: 3/3/2008; Recall Date: 2/12/2008)
     
46. What Clinicians Need to Know About MMRV Vaccine Safety - CDC (Posted: 2/28/2008)
     
47. CBER Organizational Information - Update (Posted: 2/28/2008)
     
48. FDA 101: Human Gene Therapy (2/26/2008)
     
49. Influenza Virus Vaccine 2008-2009 Season (Posted: 2/25/2008)
     
50. Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products (Posted 2/22/2008)
     
51. International Conference on Harmonisation (ICH); Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (Posted 2/21/2008)
     
52. International Conference on Harmonisation (ICH); Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 1 Residue on Ignition/Sulphated Ash General Chapter (Posted 2/21/2008)
     
53. The Eleventh US-Japan Cellular and Gene Therapy Conference on Tissue Engineering (Posted: 2/13/2008; Meeting Date: 2/28/2008)
     
54. Biological Product Shortage - Digoxin Immune Fab (Ovine) (Posted: 2/12/2008)
     
55. Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products (Posted- 2/11/2008)
     
56. Fourth Annual FDA and the Changing Paradigm for HCT/P Regulation, San Antonio, Texas - 1/8-11/2008 (Posted 2/8/2008)
    1. HCT/P Compliance Update (PDF 93 KB) - Mary Malarkey, OCBQ, CBER
    2. Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Melissa Greenwald, MD
        
57. Clinical Hold/Refusal to File Meetings - 2008 Schedule (Posted: 2/7/2008)
     
58. Approved Biological NDA and ANDA Applications - Update (Posted: 2/7/2008, Updated through: 1/31/2008)
     
59. Cleared Biological 510(k) Device Applications - Update (Posted: 2/7/2008, Updated through: 1/31/2008)
     
60. Approved Biological Premarket Approval (PMA) Device Applications - Update (Posted: 2/7/2008, Updated through: 1/31/2008)
     
61. Licensed Products and Establishments List - Update (Posted: 2/7/2008, Updated through: 1/31/2008)
     
62. Washington Vaccine Forum 2008 - 1/30/2008 (Posted 1/31/2008)
    1. Vaccine Safety and Risk Management Update (PDF 67 KB) - Florence Houn, MD, MPH
        
63. DIA Washington, D.C. Workshop - 1/14/2008 (Posted 1/29/2008)
    1. Vaccine Safety and Risk Management Update (PDF 107 KB) - Florence Houn, MD, MPH
        
64. Recall of Recall of White-Faced Hornet Venom Protein - Hollister Stier Laboratories LLC - 1/7/2008 (Posted 1/29/2008)
     
65. Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis - Update (Posted: 1/29/2008, Updated as of: 1/28/2008)
     
66. Massachusetts Biotechnology Council's Annual Luncheon - 1/22/2008 (Slide Presentation, Posted 1/25/2008)
    1. Resolutions and Revolutions – Some Perspectives (PDF 286 KB) - Jesse Goodman, MD, MPH
        
67. Regulatory Site Visit Training Program (Posted: 1/22/2008)
     
68. Biological Product Shortages - Yellow Fever Vaccine (Posted: 1/18/2008)
     
69. American Course on Drug Development and Regulatory Sciences - 1/10/2008 (Posted 1/17/2008)
    1. Vaccine Safety: An FDA Perspective (PDF - 129 KB) - Karen Midthun, MD
        
70. FDA Approves First Clotting Solution Made Using Recombinant DNA Technology (Posted 1/17/2008)
     
71. Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; Interim Final Rule; Request for Comments (Posted 12/28/2007)
     
72. Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - Slide Presentations (Posted: 12/27/2007)
     
73. Biological Product Shortages - Haemophilus influenza Type b (Hib) Conjugate (PedvaxHIB and Comvax) (Posted: 12/20/2007)
     
74. Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) - Form (Posted: 12/20/2007)
     
75. WilBio 2nd Annual Cell Banking Meeting - 12/5/2007 (Posted 12/19/2007)
    1. Regulatory Guidance on Using New Cell Substrates for Manufacture of Viral Vaccines (PDF - 250 KB) - Arifa S. Khan, PhD
        
76. User Fee Billable Products Approved Under Section 351 of the PHS Act - Update (Posted: 12/18/2007)
     
77. Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - Webcast (Posted: 12/18/2007)
     
78. Recall of PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] - Updated lot information (Posted: 12/13/2007, Recall Date: 12/11/2007)
     
79. FEDERAL REGISTER: Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Posted 12/12/2007)
     
80. Anthrax Vaccines: Bridging Correlates Of Protection In Animals To Immunogenicity In Humans - 11/8-9/2007 (Posted 11/12/2007)
    1. November 8, 2007 Transcripts
    2. November 9, 2007 Transcripts