What’s New for Biologics: Vaccines, Blood & Biologics FDA

Vaccines, Blood & Biologics
What’s New for BiologicsItems related to biologics will be added to the top of the list as they are posted on the site.

-Recently Added
... Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 821KB)
Updated: 7/21/2009
... Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 198KB)
Updated: 7/21/2009
... Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 43KB)
Updated: 7/21/2009

.Direct Recall Classification Program (Blood and Plasma)
Posted: 7/21/2009
.BK090010 - Biomixer BM330 with XBee (Wireless) Option
Posted: 7/21/2009
.Fast Track Designation Request Performance
Updated: 7/20/2009
..AFLURIA
Influenza Virus Vaccine, 2009/2010 Season Formulation, Posted: 7/20/2009
..Fluarix
Influenza Virus Vaccine, 2009/2010 Season Formulation, Posted: 7/20/2009
..FluLaval
Influenza Virus Vaccine, 2009/2010 Season Formulation, Posted: 7/20/2009
..FluMist
Influenza Virus Vaccine, 2009/2010 Season Formulation, Posted: 7/20/2009
..Fluvirin
Influenza Virus Vaccine, 2009/2010 Season Formulation, Posted: 7/20/2009
..Fluzone
Influenza Virus Vaccine, 2009/2010 Season Formulation, Posted: 7/20/2009
.Jobs at the Center for Biologics Evaluation and Research (CBER)
Senior Staff Fellow (Biology/Microbiology), Posted: 7/16/2009
.Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth
Posted: 7/16/2009
.Cytogam (Cytomegalovirus Immune Globulin Intravenous, Human) Letter
Posted: 7/16/2009
.Jobs at the Center for Biologics Evaluation and Research (CBER)
Regulatory Counsel (OD), Posted: 7/14/2009
.Jobs at the Center for Biologics Evaluation and Research (CBER)
Biomedical Engineering Technician (OVRR), Posted: 7/14/2009
.Jobs at the Center for Biologics Evaluation and Research (CBER)
Three Committee Management Specialist vacancies (OM), Posted: 7/14/2009
.American Red Cross Control Cells
Posted: 7/13/2009
.2009 CBER Foreign Regulators Seminar
Posted: 7/10/2009
.2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Announcement, Posted: 7/7/2009
.2009 Meeting Materials of the Blood Products Advisory Committee
July 20-21, 2009: Blood Products Advisory Committee Meeting Announcement, Posted: 7/6/2009
.BK090017 - SoftBank II® Version 25
Posted: 6/30/2009
.Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Updated: 6/30/2009

Workshops, Meetings & Conferences (Biologics)
*Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components, Posted: 6/29/2009

Administrative Actions (Biologics)
-- Notice of Intent to Revoke (NOIR) Letter: Immucor, Inc., Posted: 6/26/2009
-Jobs at the Center for Biologics Evaluation and Research (CBER)
Epidemiologist (General Register & Direct Hire), Posted: 6/26/2009
-Jobs at the Center for Biologics Evaluation and Research (CBER)
Pharmacologist (General Register & Direct Hire), Posted: 6/26/2009
-Jobs at the Center for Biologics Evaluation and Research (CBER)
Senior Staff Fellow (OVRR), Posted: 6/25/2009
-Jobs at the Center for Biologics Evaluation and Research (CBER)
-Chief, Therapeutics and Blood Safety Branch (OBE), Posted: 6/25/2009
-BK960004 - Defense Blood Standard System (DBSS), version 1.0/1.03
Posted: 6/25/2009
-COBAS TaqScreen MPX Test
Updated: 6/24/2009
-Ortho ProVue™, Software Version 3.1
Posted: 6/23/2009

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What’s New for Biologics