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Preview: What's New: Vaccines, Blood & Biologics RSS Feed

What's New: Vaccines, Blood & Biologics RSS Feed



Documents recently posted on the CBER Web Site



Last Build Date: Wed, 25 Feb 2009 08:24:00 -0500

 



RotaTeq

Wed, 22 Mar 2017 15:42:00 -0400




Zostavax

Wed, 22 Mar 2017 15:16:00 -0400




Complete List of Substantially Equivalent 510(k) Device Applications

Thu, 16 Mar 2017 09:09:00 -0400

Information updated through January 31, 2017



AFLURIA

Wed, 15 Mar 2017 12:39:00 -0400




INFANRIX

Tue, 14 Mar 2017 09:23:00 -0400




Biologics PREA Reviews and Labeling Changes

Mon, 13 Mar 2017 18:53:00 -0400

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.



Fluarix

Mon, 13 Mar 2017 18:12:00 -0400

For active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information.



FluMist

Mon, 13 Mar 2017 13:19:00 -0400




Varivax

Mon, 13 Mar 2017 08:56:00 -0400




ENGERIX-B

Mon, 13 Mar 2017 07:33:00 -0400




FluLaval

Fri, 10 Mar 2017 13:14:00 -0500




TWINRIX

Fri, 10 Mar 2017 12:52:00 -0500

Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus



VAQTA

Fri, 10 Mar 2017 12:07:00 -0500




Fluzone, Fluzone High-Dose and Fluzone Intradermal

Fri, 10 Mar 2017 09:00:00 -0500




HAVRIX

Fri, 10 Mar 2017 07:58:00 -0500

Package Insert Updated December 2009 to include additional adverse events.



Patient Touch™ Blood Product Administration System v3.2.1

Fri, 03 Mar 2017 14:48:00 -0500

Stand Alone, Blood Bank Software



DailyChek QC Kit

Fri, 03 Mar 2017 12:06:00 -0500

American Red Cross DailyChek QC Kit is intended for quality control of blood bank reagent red blood cells.



Jobs at the Center for Biologics Evaluation and Research (CBER)

Thu, 02 Mar 2017 10:00:00 -0500

Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010



Kogenate FS

Thu, 02 Mar 2017 09:19:00 -0500




TISSEEL

Thu, 02 Mar 2017 09:10:00 -0500