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Documents recently posted on the CBER Web Site

Last Build Date: Thu, 06 Dec 2012 17:30:00 -0500


EVARREST (Fibrin Sealant Patch)

Thu, 13 Oct 2016 14:09:00 -0400

Complete List of Substantially Equivalent 510(k) Device Applications

Thu, 13 Oct 2016 13:47:00 -0400

Information updated through September 30, 2016

Draft Agenda - Day 1

Thu, 13 Oct 2016 09:35:00 -0400

Biologics PREA Reviews and Labeling Changes

Thu, 06 Oct 2016 16:15:00 -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.


Mon, 03 Oct 2016 08:14:00 -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.

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

Tue, 27 Sep 2016 12:30:00 -0400

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