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Zold - Biotech/Pharma - FDA - CBER
Eden Biodesign's U.S. Technical Director to Present at 2009 BIO International Convention in May 5/5/2009
CBER: User Fee Billable Products Approved Under Section 351 of the PHS Act Updated 9/26/2008
CBER: Medical Device Notification Sunquest Laboratory Blood Bank and Blood Donor Modules 9/5/2008
CBER: Blood Grouping Reagent Anti-s (Monoclonal) (Seraclone) - Summary Basis for Regulatory Action 9/3/2008
CBER: Influenza Virus Vaccine 2008-2009 Season 8/27/2008
CBER: Substantially Equivalent 510(k) Device Information for Biotest Diagnostics Corporation 8/22/2008
CBER Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update 8/20/2008
CBER: Recall: Antihemophilic Factor, Human - CSL Behring 8/19/2008
CBER: Substantially Equivalent 510(k) Device for Cymbal Automated Blood Collection System, Haemonetics Corporation (HAE) 8/18/2008
CBER: Supplement Approval: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (PROCLEIX ULTRIO Assay) Gen-Probe Incorporated (GPRO) 8/15/2008
CBER: List of Substantially Equivalent 510(k) Device Applications 8/13/2008
CBER: Approved Premarket Approval (PMA) Device Applications 8/13/2008
CBER: Approved NDA and ANDA Applications 8/13/2008
CBER: Licensed Products and Establishments List Update 8/13/2008
CBER: Influenza Virus Vaccine 2008/2009 Season Lot Release Status Update 8/13/2008
CBER: Blood Products Advisory Committee Meeting 8/12/2008
CBER: Influenza Virus Vaccine 2008/2009 Season Lot Release Status 8/6/2008
CBER: Nucleic Acid Testing to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products 7/30/2008
CBER: Supplement Approval: Influenza Virus Vaccine (FluLaval) 7/28/2008
CBER: Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency 7/17/2008
CBER: Letter: Coagulation Factor IX (Recombinant) (BeneFIX) - Wyeth Pharmaceuticals, Inc. 7/17/2008



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