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Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) Posted: 11/8/2004 2004 Biological Approvals - Update Posted: 11/5/2004, Updated through: 10/31/2004 Smallpox Vaccine, Dried, Calf Lymph Type - Inclusion of Black Box Warning (Wyeth Pharmaceuticals, Inc) Posted: 11/5/2004, Approval Date: 11/5/2004 Licensed Products and Establishments List - Update Posted: 11/4/2004, Updated through: 10/31/2004 Influenza Vaccine Lot Release Information - Update Posted: 11/4/2004, Status as of: 11/3/2004 User Fee Billable Products Approved Under Section 351 of the PHS Act - Update Posted: 11/3/2004, Update Date: 11/3/2004 Human Cell, Tissues and Cellular and Tissue-Based Products - List of Registered Establishments - Update Posted: 11/3/2004, Updated through: 11/2/2004 BioWest 2004 Conference (Slides) Posted: 11/2/2004, Meeting Date: 10/27/2004 Vacancy Announcement - Biologist, OVRR/DBP/LBP Posted: 11/2/2004 Approved Biologics NDA and ANDA Applications - Update Posted: 11/1/2004, Updated through: 10/29/2004 Cleared Biologics 510(k) Device Applications - Update Posted: 11/1/2004, Updated through: 10/29/2004 Approved Biologics Premarket Approval (PMA) Device Applications - Update Posted: 11/1/2004, Updated through: 10/29/2004 Substantially Equivalent 510(k) Device - ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 - Boston Biomedica, Inc Posted: 11/1/2004, Clearance Date: 10/29/2004 Substantially Equivalent 510(k) Device - Blood Bank Control System (BBCS) 5.0 - Blood Bank Computer Systems, Inc Posted: 11/1/2004, Clearance Date: 10/22/2004 Substantially Equivalent 510(k) Device - LifeTec Donor Verification and Collection System (DOVAC) 1.00 - SysTec Computer Associates, Inc Posted: 11/1/2004, Clearance Date: 10/21/2004 Substantially Equivalent 510(k) Device - Quality Donor System 2004 2.0 - Talisman Ltd Posted: 11/1/2004, Clearance Date: 10/18/2004 Substantially Equivalent 510(k) Device - Misys Laboratory Blood Bank and Blood Donor 6.0.1 - Misys Healthcare Systems Posted: 10/29/2004, Clearance Date: 10/22/2004 FDA Names Dr. Edward Otto as New Director of the Office of Cellular, Tissue and Gene Therapies Posted: 10/29/2004, Issue Date: 10/28/2004 News Release - HHS Identifies More Influenza Vaccine Posted: 10/28/2004, Issue Date: 10/28/2004 Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update Posted: 10/28/2004, Updated through: 10/28/2004 Influenza Vaccine Lot Release Information Posted: 10/28/2004, Status as of 10/27/2004 Substantially Equivalent 510(k) Device - Trima Automated Blood Component Collection System - Blood Component Sampling Accessary - Gambro BCT, Inc Posted: 10/28/2004, Clearance Date: 10/28/2004 Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes Posted: 10/28/2004, Publish Date: 10/28/2004 Recall of ORTHO Antibody to HBsAg ELISA Test System 3 - Ortho Clinical Diagnostics, Inc Posted: 10/26/2004, Recall Date: 9/20/2004 Warning Letter - Richards, Jon M., M.D., Ph.D. Posted: 10/26/2004, Issue Date: 10/4/2004 Warning Letter - Frenette, Gary, M.D., Ph.D. Posted: 10/26/2004, Issue Date: 10/4/2004 Vacancy Announcement - Supervisory Consumer Safety Officer, OCBQ/DIS Posted: 10/25/2004 Influenza Vaccine Lot Release Information Posted: 10/21/2004, Status as of 10/20/2004 Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV Posted: 10/21/2004, Publish Date: 10/28/2004 Warning Letter - Aventis Behring, L.L.C. Posted: 10/19/2004, Issue Date: 10/12/2004 Fast Track Designation Request Performance Posted: 10/19/2004 RAPS 2004 - Annual Conference and Exhibition (Slides) Posted: 10/19/2004, Meeting Date: 10/12/2004 2004 Chiron Flu Vaccine Chronology Posted: 10/18/2004 FDA Team Completes Inspection of Chiron’s Liverpool Flu Vaccine Plant Posted: 10/18/2004, Issue Date: 10/15/2004 Substantially Equivalent 510(k) Device - Check cell (Weak) - Immucor, Inc Posted: 10/18/2004, Clearance Date: 10/6/2004 World Vaccine Congress (Slides) Posted: 10/15/2004, Meeting Date: 10/11-13/2004 CBER Critical Path Workshop (Slides) Posted: 10/15/2004, Workshop Date: 10/7/2004 HHS Secretary Urges States to Aggressively Prosecute Flu Vaccine Price Gouging Posted: 10/14/2004, Issue Date: 10/14/2004 Substantially Equivalent 510(k) Device - ACCURUN 315 HIV-1 RNA Positive Control - Boston Biomedica, Inc Posted: 10/14/2004, Clearance Date: 10/12/2004 Influenza Vaccine Lot Release Information Posted: 10/14/2004, Status as of 10/13/2004 FDA and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Working Cooperatively to Address Flu Vaccine Quality at Chiron's U.K. Facility Posted: 10/14/2004, Issue Date: 10/13/2004 Warning Letter - Sokol, Dawn M., M.D. Posted: 10/13/2004, Issue Date: 9/10/2004 Influenza Vaccine Lot Release Information Posted: 10/12/2004 510(k) Summary: Amicus Separator System - Baxter Healthcare Corp, Transfusion Therapies Division Posted: 10/8/2004, Clearance Date: 9/24/2004 510(k) Summary: Scansytem Bacterial Detection Device - Hemosystem, S.A. Posted: 10/8/2004, Clearance Date: 9/23/2004 Substantially Equivalent 510(k) Device - LOGIC 2.0 - Fifth Dimension Information Systems Posted: 10/8/2004, Clearance Date: 10/6/2004 FDA Plasma Standards Workshop (Additional Slide Presentation) Posted: 10/7/2004, Meeting Date: 8/31/2004 Transcript - Workshop on Plasma Standards Posted: 10/7/2004, Meeting Date: 8/31/2004 Product Shortage - Influenza Virus Vaccine, Fluvirin - Chiron Corp Posted: 10/6/2004, Date of Onset: 10/5/2004 Interim Influenza Vaccination Recommendations - 2004–2005 Influenza Season - CDC Posted: 10/6/2004, Issue Date: 10/5/2004 HHS Statement on Chiron Flu Vaccine - Flu Vaccine 2004-2005 Season Update Posted: 10/5/2004, Issue Date: 10/5/2004 Scientific Considerations Related to Developing Follow-On Protein Products (Slide Presentations) Posted: 10/5/2004, Meeting Date: 9/14-15/2004

Updated November 5, 2004

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