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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
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