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Documents recently posted on the CBER Web Site



Last Build Date: Fri, 18 Sep 2009 18:06:00 -0400

 



Gammaplex 5% & 10%

Fri, 17 Feb 2017 12:42:00 -0500

October 7, 2009 letter corrects the storage temperature stated on page 1, paragraph 5. Posted: 12/11/2009



EVITHROM

Fri, 17 Feb 2017 08:41:00 -0500




CEPROTIN

Fri, 17 Feb 2017 08:34:00 -0500




OCTAGAM

Fri, 17 Feb 2017 08:31:00 -0500




ORTHO T. cruzi ELISA Test System

Fri, 17 Feb 2017 07:03:00 -0500




Auszyme Monoclonal

Fri, 17 Feb 2017 06:50:00 -0500

CBER Auszyme Monoclonal Product Approval Information



Biologics PREA Reviews and Labeling Changes

Thu, 09 Feb 2017 09:50:00 -0500

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.



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

Wed, 08 Feb 2017 08:33:00 -0500

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



Complete List of Substantially Equivalent 510(k) Device Applications

Wed, 08 Feb 2017 07:11:00 -0500

Information updated through January 31, 2017



Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Tue, 07 Feb 2017 09:03:00 -0500

Vaccine lot release information updated on 3/3/2010.



Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry

Wed, 25 Jan 2017 09:13:00 -0500

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.