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Vacancy Announcement - Medical Officer, Deputy Director for Medical Affairs, DH/OBRR
Posted: 7/23/2008

Information from CDC and FDA on the Safety of Gardasil Vaccine
Posted: 7/22/2008

Supplement Approval: Influenza Virus Vaccine (Fluzone) - 2008-2009 United States formulation
Posted: 7/22/2008, Approval Date: 7/14/2008

Public Workshop: Animal Models for the Treatment of Acute Radiation Syndrome
Posted: 7/22/2008; Meeting Date: 9/17 - 18/2008

FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
Posted: 7/21/2008

Supplement Approval: Influenza Virus Vaccine (Fluzone)
Posted: 7/21/2008, Approval Date: 7/14/2008

Public Workshop: Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products
Posted: 7/21/2008: Workshop Date: 9/22-23/2008

Supplement Approval: Influenza Virus Vaccine Live, Intranasal (FluMist)
Posted: 7/21/2008, Approval Date: 7/3/2008

Approval History - Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine (Pentacel)
Posted: 7/18/2008

Health Care Personnel Initiative to Improve Influenza Vaccination Toolkit
Posted: 7/17/2008

Medical Device Notification (PSN-08-05) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc.
Posted: 7/17/2008; Notification Date: 6/24/2008

Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
Posted: 7/17/2008

Letter: Coagulation Factor IX (Recombinant) (BeneFIX) - Wyeth Pharmaceuticals, Inc
Posted: 7/17/2008

Vacancy Announcement - Public Health Analyst, OCTMA
Posted: 7/16/2008

Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials; Final Rule
Posted: 7/15/2008

Guidance for Industry: CGMP for Phase 1 Investigational Drugs
Posted: 7/15/2008

Vacancy Announcement - Program Analyst, PSB/DPS/OM
Posted: 7/15/2008

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing
Posted: 7/11/2008

DIA/FDA Critical Path Initiative (CPI) on the Move Conference
Posted: 7/11/2008; Workshop Date: 9/15/2008

Final Rule: Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications (Federal Register)
Posted: 7/10/2008

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine (Pentacel) - Summary Basis of Regulatory Action
Posted: 7/10/2008

Vacancy Announcement - Regulatory Information Specialist, ADRM/OD
Posted: 7/9/2008

Fast Track Designation Request Performance Report - Update
Posted: 7/9/2008

Approved Biological NDA and ANDA Applications - Update
Posted: 7/9/2008, Updated through: 6/30/2008

Cleared Biological 510(k) Device Applications - Update
Posted: 7/9/2008, Updated through: 6/30/2008

Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 7/9/2008, Updated through: 6/30/2008

Substantially Equivalent 510(k) Device: IntelliDOT Blood Product Administration - IntelliDOT Corporation
Posted: 7/8/2008, Clearance Date: 6/13/2008

Licensed Products and Establishments List - Update
Posted: 7/7/2008, Updated through: 6/30/2008

Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Cells, Tissues, and Cellular and Tissue-Based Products; Request for Data (Federal Register)
Posted: 7/7/2008

Vacancy Announcement - Mathematical Statistician, DETTD/OBRR
Posted: 7/3/2008

FDA Workshop on Approaches to Reduce Risk of Transfusion Transmitted Babesiosis in the United States
Posted: 7/3/2008; Meeting Date: 9/12/2008

Vacancy Announcement - Senior Staff Fellow, DH/OBRR
Posted: 6/30/2008

Medical Device Notification - Sunquest Laboratory Blood Bank and Blood Donor Modules
Posted: 6/30/2008; Notification Date: 6/5/2008

Urgent Product Correction - Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test
Posted: 6/30/2008; Correction Date: 6/6/2008

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update
Posted: 6/30/2008, Updated as of: 6/28/2008

BIO, International Convention, San Diego, California - Slide Presentation
Posted: 6/27/2008

Substantially Equivalent 510(k) Device: ALYX Component Collection System - Fenwal Inc.
Posted: 6/27/2008, Clearance Date: 6/24/2008

Vacancy Announcement - Senior Staff Fellow, DBPAP/OVRR
Posted: 6/27/2008

Pediatric Research Equity Act of 2007 (PREA) - Updated Product information
Posted: 6/26/2008

Product Approval: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine (KINRIX)
Posted: 6/25/2008

Correction of AUSZYME Monoclonal Assay - Abbott Laboratories
Posted: 6/24/2008; Correction Date: 6/12/2008

Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback" (Federal Register)
Posted: 6/24/2008

Vaccines and Related Biological Products Advisory Committee Roster - Updated
Posted: 6/23/2008

Vacancy Announcement - Health Scientist (HS)/Lead/Supv HS-Direct Hire
Posted: 6/23/2008

 
Updated: July 23, 2008