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Vacancy Announcement - Supervisory Interdisciplinary Scientist, AEB or VSB/DE/OBE
Posted: 9/16/2008

Vacancy Announcement - Supervisory Medical Officer, AEB or VSB/DE/OBE
Posted: 9/16/2008

Supplement Approval: Rotavirus Vaccine, Live, Oral, Pentavalent
Posted:9/16/2008, Approval Date: 9/5/2008

SOPP 8119: Handling of Regulatory Electronic Communications
Posted: 9/16/2008

13th Annual GMP by the Sea: CBER Update - Slide Presentation
Posted: 9/16/2008

SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments
Posted: 9/15/2008

Substantially Equivalent 510(k) Device - MCS+ 9000 System
Posted: 9/15/2008, Clearance Date: 9/15/2008

Substantially Equivalent 510(k) Device - Trima Accel Automated Blood Component Collection System, COBE Spectra Apheresis System
Posted: 9/15/2008, Clearance Date: 9/15/2008

Substantially Equivalent 510(k) Device - PLASMALINK
Posted: 9/15/2008, Clearance Date: 9/8/2008

FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
Posted: 9/15/2008

FDA Approves Treatment for Rare Neurologic Disease
Posted: 9/15/2008

Approval Information: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil) - Merck
Posted: 9/12/2008; Approval Date: 9/12/2008

Approval Information: Immune Globulin Intravenous (Human) (Gamunex) - Talecris Biotherapeutics, Inc.
Posted: 9/12/2008; Approval Date: 9/12/2008

Substantially Equivalent 510(k) Device - Pool Results Manager Version 1.0C
Posted: 9/12/2008, Clearance Date: 9/3/2008

Important Notification: Red Cell Collection Kits - Haemonetics Corporation
Posted: 9/12/2008: Notification Date: 9/9/2008

Approval Information: Blood Grouping Reagent Anti-Fya (Monoclonal) (Seraclone) - Approval History and Related Documents
Posted: 9/12/2008

Approval Information: Blood Grouping Reagent Anti-S (Monoclonal) (Seraclone) - Approval History and Related Documents
Posted: 9/12/2008

Approval Information: Blood Grouping Reagent Anti-s (Monoclonal) (Seraclone) - Approval history and related documents
Posted: 9/12/2008

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 9/10/2008

Vacancy Announcement - Supervisory Medical Officer, DVRPA/OVRR
Posted: 9/9/2008

Vacancy Announcement - Supervisory Interdisciplinary Scientist, DVRPA/OVRR
Posted: 9/9/2008

Concept Paper: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule (PDF)
Posted: 9/9/2008

Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] - Genzyme Corporation
Posted: 9/9/2008, Recall Date: 8/22/2008

FEDERAL REGISTER: Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, Final Rule
Posted: 9/8/2008

Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases
Posted: 9/8/2008

Licensed Products and Establishments List - Update
Posted: 9/5/2008, Updated through: 8/31/2008

Cleared Biological 510(k) Device Applications - Update
Posted: 9/5/2008, Updated through: 8/31/2008

Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 9/5/2008, Updated through: 8/31/2008

Approved Biological NDA and ANDA Applications - Update
Posted: 9/5/2008, Updated through: 8/31/2008

Medical Device Notification (PSN-08-06) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc.
Posted: 9/5/2008, Recall Date: 8/15/2008

International Conference on Harmonisation (ICH); Draft Guidance: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials andMarketing Authorization for Pharmaceuticals
Posted: 9/4/2008

Vaccines and Related Biological Products Advisory Committee Meeting
Posted: 9/3/2008, Meeting Date: 9/25/2008

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 9/3/2008

Approval Information: Blood Grouping Reagent Anti-S (Monoclonal) (Seraclone) - Summary Basis for Regulatory Action
Posted: 9/3/2008

Approval Information: Blood Grouping Reagent Anti-s (Monoclonal) (Seraclone) - Summary Basis for Regulatory Action
Posted: 9/3/2008

Approval Information: Blood Grouping Reagent Anti-Fya (Monoclonal) (Seraclone) - Summary Basis for Regulatory Action
Posted: 9/3/2008

Public Workshop: Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products - Agenda
Posted: 9/2/2008

Draft Guidance for Industry on Integrated Summary of Effectiveness
Posted: 8/27/2008

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 8/27/2008

FEDERAL REGISTER: FDA Regulations; Technical Amendment; Final Rule
Posted: 8/26/2008

Approval Information: Blood Grouping Reagents and Anti-Human Globulin Reagents - Biotest Medical Diagnostics GmbH
Posted: 8/25/2008, Approval Date: 8/14/2008

Substantially Equivalent 510(k) Device - Seraclone Control ABO+Rh; Coombscell-E; MLB2
Posted: 8/22/2008, Clearance Date: 7/23/2008

Approval Information: Reagent Red Blood Cells and Reagent Red Blood Cells For Use in Automated Systems (Biotestcell and Erytypecell) - Biotest Medical Diagnostics GmbH
Posted: 8/21/2008, Approval Date: 8/14/2008

Approval Information: Blood Grouping Reagents (Erytype S) - Biotest Medical Diagnostics GmbH
Posted: 8/21/2008, Approval Date: 8/14/2008

Substantially Equivalent 510(k) Device - Tango Optimo Automated Blood Bank Analyzer System
Posted: 8/21/2008, Clearance Date: 7/23/2008

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 8/20/2008

Recall: Antihemophilic Factor, Human - CSL Behring L.L.C.
Posted: 8/19/2008, Recall Date: 8/18/2008

Substantially Equivalent 510(k) Device - Cymbal Automated Blood Collection System - Haemonetics Corp
Posted: 8/18/2008, Clearance Date: 8/15/2008

Approval Information: Blood Grouping Reagent Anti-S (Monoclonal) (Seraclone)
Posted: 8/15/2008, Approval Date: 8/14/2008

Approval Information: Blood Grouping Reagent Anti-s (Monoclonal) (Seraclone)
Posted: 8/15/2008, Approval Date: 8/14/2008

Approval Information: Blood Grouping Reagent Anti-Fya (Monoclonal) (Seraclone)
Posted: 8/15/2008, Approval Date: 8/14/2008

Supplement Approval: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic) (PROCLEIX ULTRIO Assay) - Gen-Probe Inc
Posted: 8/15/2008, Approval Date: 8/12/2008

Substantially Equivalent 510(k) Device - SoftBank II v23.2 - SCC Soft Computer
Posted: 8/15/2008, Clearance Date: 8/12/2008

Substantially Equivalent 510(k) Device - Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 - LifeSouth Community Blood Centers Inc
Posted: 8/15/2008, Clearance Date: 8/5/2008

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 8/13/2008

Cleared Biological 510(k) Device Applications - Update
Posted: 8/13/2008, Updated through: 7/31/2008

Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 8/13/2008, Updated through: 7/31/2008

Approved Biological NDA and ANDA Applications - Update
Posted: 8/13/2008, Updated through: 7/31/2008

Licensed Products and Establishments List - Update
Posted: 8/13/2008, Updated through: 7/31/2008

Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - Transcripts
Posted: 8/12/2008

Blood Products Advisory Committee Meeting
Posted: 8/12/2008; Meeting Date: 9/10-11/2008

CBER Foreign Regulators Seminar Agenda
Posted: 8/12/2008; Meeting Date: 10/14-16/2008

Letter: Regenerative Sciences, Inc
Posted: 8/11/2008

Substantially Equivalent 510(k) Device - Donor Screen HLA Class I and Class II - GTI, INC
Posted: 8/11/2008, Clearance Date: 7/30/2008

Substantially Equivalent 510(k) Device - XM-ONE Transplantation Cross Match - AbSorber AB
Posted: 8/11/2008, Clearance Date: 7/29/2008

Substantially Equivalent 510(k) Device - ALBAcheck - BGS Reagent Control for Anti-D -ALBA Bioscience
Posted: 8/11/2008, Clearance Date: 7/29/2008

Vacancy Announcement - Administrative Support Assistant (OA), WOPT/OM
Posted: 8/11/2008

Public Workshop: America's Blood Centers: Blood Establishment Computer Software (BECS) Conference - Transcripts
Posted: 8/8/2008

 
Updated: September 16, 2008