jueves, 25 de junio de 2009

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
. 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 cada uno de los archivos precitados (PDF en idioma inglés únicamente):
What’s New for Biologics

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