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Approval Information: RiaSTAP [Fibrinogen Concentrate (Human)]
Posted: 1/16/2009

Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Posted: 1/16/2009

Approval Information: Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay- Summary Basis for Approval
Posted: 1/15/2009

Vacancy Announcement - Director, DH/OBRR
Posted: 1/15/2009

Fast Track Designation Request Performance Report - Update
Posted: 1/12/2009

International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter
Posted: 1/9/2009

International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter
Posted: 1/9/2009

Approved Premarket Approval (PMA) Device Applications - Update
Posted: 1/8/2009

Substantially Equivalent 510(k) Device Applications - Update
Posted: 1/8/2009

Approved NDA and ANDA Applications - Update
Posted: 1/8/2009

Approval Information- (ANDA) Anticoagulant Citrate Phosphate Dextrose Solution (CPD)
Posted: 1/8/2009 Approved: 1/6/2009

Biological Product Shortages - Recombivax HB (Merck & Co.)
Posted: 1/7/2009

Meeting of the Blood Products Advisory Committee - Updated
Posted: 1/6/2009

Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices
Posted: 1/5/2009

Adjuvants and Adjuvanted Preventative and Therapeutic Vaccines for Infectious Disease Indications - Presentations
Posted: 1/2/2009

Approval Information: Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay - COBAS TaqScreen MPX Test
Posted: 12/31/2008

FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue
Posted: 12/31/2008

CBER Organizational Charts
Posted: 12/29/2008

Vacancy Announcement - Director, DHT/OCTGT
Posted: 12/23/2008

Vacancy Announcement - Supervisory Genetic Epidemiologist, OBE
Posted: 12/23/2008

Substantially Equivalent 510(k) Device -Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System - Arthrex Incorporated
Posted: 12/19/2008, Clearance Date: 12/12/2008

Electronic Biological Product Deviation Reporting (eBPDR) Instructions for Using the eBPDR System - Update
Posted: 12/19/2008

Electronic Biological Product Deviation Reporting (eBPDR) Latest System Changes - Update
Posted: 12/19/2008

Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
Posted: 12/19/2008

Vacancy Announcement - Pharmacology/Toxicology Reviewer, DCEPT/OCTGT
Posted: 12/18/2008

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 12/17/2008

 
Updated: January 16, 2009