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Documents recently posted on the CBER Web Site



Last Build Date: Mon, 09 Feb 2009 10:12:00 -0500

 



Anti-B (Murine Monoclonal)

Tue, 10 Oct 2017 09:27:00 -0400




Procleix West Nile Virus (WNV) Assay

Tue, 10 Oct 2017 08:38:00 -0400




COBAS TaqScreen West Nile Virus Test

Tue, 10 Oct 2017 08:31:00 -0400




Package Insert - TWINRIX

Tue, 03 Oct 2017 14:31:00 -0400




SOPP 8406: CBER Processing of PDUFA Application Payments

Fri, 29 Sep 2017 13:11:00 -0400

This document describes the procedures used to determine the accuracy of information submitted by an applicant and to verify user fee payments relative to the Prescription Drug User Fee Act (PDUFA) of 1992, as reauthorized by the Food and Drug Administration Amendments Act of 2007. In addition, this document identifies other user fee activities for which the Office of Management’s Regulatory Information Management Staff (RIMS) is responsible.



Procleix HIV-1/HCV Assay

Wed, 27 Sep 2017 16:16:00 -0400




Privigen

Tue, 19 Sep 2017 14:57:00 -0400