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Importance of Influenza Vaccination for Health Care Personnel
Posted: 10/31/2008
SOPP 8014: Procedures for the Preparation, Routing, and Issuance of Regulations
Posted:10/30/2008
Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 10/29/2008
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update
Posted: 10/29/2008
Important Notification: North American Coral Snake Antivenin (Micruris fulvius) (Equine) Lot 4030026
Posted: 10/28/2008
Vacancy Announcement - Director - DE/OBE
Posted: 10/27/2008
Approval Information: C1 Esterase Inhibitor (Human) (CINRYZE) - Summary Basis for Regulatory Action
Posted: 10/27/2008
Vacancy Announcement - Regulatory Information Specialist - CTB/DCCA/OCTMA
Posted: 10/27/2008
CBER Foreign Regulators Seminar - Update
Posted: 10/23/2008
CBER 2007 Annual Report
Posted: 10/22/2008
Substantially Equivalent 510(k) Device - Atreus Whole Blood Processing System - CaridianBCT, Inc.
Posted:10/22/2008, Clearance Date: 9/29/2008
Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 10/22/2008
Supplement Approval: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil) - Clinical Review
Posted:10/22/2008
Vacancy Announcement - Biologist/Lead/Supv Biologist
Posted: 10/21/2008
Vacancy Announcement - Chemist/Lead/Supv Chemist
Posted: 10/21/2008
Vacancy Announcement - Division Director, DOE/OBE
Posted: 10/21/2008
Vacancy Announcement - Epidemiologist/Lead/Supv Epidemiologist
Posted: 10/21/2008
Vacancy Announcement - Microbiologist /Lead /Supv Microbiologist
Posted: 10/21/2008
Vacancy Announcement - Pharmacologist /Lead /Supv Pharmacologist
Posted: 10/21/2008
Current Licensed Establishments and Products by Product - Update
Posted: 10/21/2008
Current Licensed Establishments and Products by Establishment - Update
Posted: 10/21/2008
Fast Track Designation Request Performance Report - Update
Posted: 10/21/2008
Cleared Biological 510(k) Device Applications - Update
Posted: 10/20/2008, Updated through: 9/30/2008
Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 10/20/2008, Updated through: 9/30/2008
Approved Biological NDA and ANDA Applications - Update
Posted: 10/20/2008, Updated through: 9/30/2008
Draft Guidance for Industry on Tropical Disease Priority Review Vouchers
Posted: 10/20/2008
Vacancy Announcement - Senior Staff Fellow-(Microbiology), DBPAP/OVRR
Posted: 10/17/2008
Substantially Equivalent 510(k) Device - AMICUS® Separator: Software 3.1 with EDI Export
- Fenwal Inc.
Posted:10/16/2008, Clearance Date: 10/2/2008
Public Workshop: Adjuvants and Adjuvanted Preventative and Therapeutic Vaccines for Infectious Disease Indications
Posted: 10/16/2008; Meeting Dates: 12/2-3/2008
Substantially Equivalent 510(k) Device - Cell Freeze Liquid Nitrogen Freezing Container
- Charter Medical, Ltd.
Posted:10/15/2008, Clearance Date: 10/3/2008
Approval Information: Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid
Conjugate Vaccine (Menactra) - Sanofi Pasteur Inc.
Posted: 10/15/2008, Approval Date: 10/7/2008
Approval Information: C1 Esterase Inhibitor (Human) (CINRYZE) - Lev Pharmaceuticals, Inc.
Posted: 10/10/2008, Approval Date: 10/10/2008
FDA Licenses for Marketing New Therapy for Rare Genetic Disease
Posted: 10/10/2008
Supplement Approval: Antihemophilic Factor (Recombinant) Kogenate FS - Bayer HealthCare LLC.
Posted: 10/10/2008, Approval Date: 10/10/2008
FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
Posted: 10/10/2008
Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
Posted: 10/9/2008
Vacancy Announcement - Engineers (Mechanical, Electrical and Biomedical Engineer)
Posted: 10/8/2008
Vacancy Announcement - Engineers (Mechanical, Electrical and Biomedical Engineer)
Posted: 10/8/2008
Medical Device Notification (PSN-08-09) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc.
Posted: 10/7/2008, Recall Date: 9/30/2008
Vacancy Announcement - Mathematical Statistician, OBE
Posted: 10/7/2008
Draft Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Product (PDF - 125 KB)
Posted: 10/7/2008; Issued: 9/30/2008
PDUFA Pilot Project Proprietary Name Review; Concept Paper (PDF -295 KB)
Posted: 10/7/2008; Issued: 9/30/2008
Untitled Letter: Antithrombin III, Human (Thrombate III), Talecris Biotherapies, Inc.
Posted: 10/7/2008
Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) Alphabetical List of Registered Establishments
Posted: 10/6/2008
Vacancy Announcement - Medical Officer, DVRPA/OVRR
Posted: 10/6/2008
Public Workshop: Workshop to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States - Transcript
Posted: 10/3/2008
Approval Information: Tuberculin, Purified Protein Derivative (Aplisol) - JHP Pharmaceuticals, LLC
Posted: 10/1/2008, Approval Date: 9/23/2008
Approval Information: Blood Grouping Reagent Anti-e (Monoclonal) Corrected Approval Letter - Biotest Medical Diagnostics GmbH
Posted: 09/26/2008, Approval Date: 9/23/2008
PDUFA - User Fee Billable Products Approved Under Section 351 of the PHS Act - Updated
Posted: 9/26/2008
Substantially Equivalent 510(k) Device - HEMERUS LEUKOSEP ® HRC-600-C Leukocyte Reduction Filtration
System - Hemerus Medical, LLC
Posted: 9/25/2008, Clearance Date: 9/11/2008
Approval Information: Protein C Concentrate (Human) - Summary Basis for Approval - Baxter Healthcare Corp.
Posted 9/25/2008
Information About Heparin and Plasma Derived Products
Posted: 9/25/2008
SOPP 8416: CBER Initiated Second Level STNs
Posted: 9/24/2008
SOPP 8116: Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff
Posted: 9/23/2008
Vacancy Announcement - Biologist/Lead/Supv Biologist
Posted: 9/19/2008
Vacancy Announcement - Microbiologist /Lead /Supv Microbiologist
Posted: 9/19/2008
FEDERAL REGISTER: FDA Regulations; Technical Amendment; Final Rule; Correction
Posted: 9/19/2008
Public Workshop: Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry
Posted: 9/19/2008
Supplement Approval: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil) - Statistical Review and Evaluation
Posted:9/18/2008
PDA/FDA Joint Meeting - Slide Presentations
Posted: 9/18/2008
Vacancy Announcement - Consumer Safety Officer (CSO)/Lead /Supv CSO
Posted: 9/18/2008
Vacancy Announcement - Consumer Safety Officer (CSO)/Lead /Supv CSO
Posted: 9/18/2008
International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity
Studies
Posted: 9/17/2008
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