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CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
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What's New

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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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