What’s New for Biologics

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

-Recently Added
* 2009 Meeting Materials of the Blood Products Advisory Committee
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
-Clinical Investigator Status (Biologics)
Posted: 6/16/2009
-Jobs at the Center for Biologics Evaluation and Research (CBER)
-Interdisciplinary Scientist (General Register), Updated: 6/16/2009
-Pneumococcal Vaccine, Polyvalent
-Pneumovax 23, Updated: 6/15/2009
-Jobs at the Center for Biologics Evaluation and Research (CBER)
-Chemist (OVRR), Updated: 6/14/2009
-Varicella Virus Vaccine Live
Varivax, Updated: 6/11/2009
-Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Gardasil, Updated: 6/10/2009
-Ortho Verseia™ Pipetter as part of the Ortho Summit™ System
Updated: 6/8/2009
-Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 820KB)
Updated: 6/4/2009
-Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 58KB)
Updated: 6/4/2009
-Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 164KB)
Updated: 6/4/2009
-Complete List of Licensed Products and Establishments
Updated: 6/4/2009
-2009 Meeting Materials, Transmissible Spongiform Encephalopathies Advisory Committee
Updated: 6/4/2009
-About the FDA.gov Redesign
Posted: 6/4/2009
-Investigation of whether the acute hemolysis associated with Rho(D) immune globulin intravenous (human) administration for treatment of immune thrombocytopenic purpura is consistent with the acute hemolytic transfusion reaction model (PDF - 150KB)
Posted: 6/3/2009

abrir aquí para acceder a los documentos previamente listados:
What’s New for Biologics