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Documents recently posted on the CBER Web Site
Updated: 56 min 53 sec ago

Procleix HIV-1/HCV Assay

2 hours 10 min ago
Categories: FDA News

Abbott Prism Chagas

Wed, 10/18/2017 - 06:08
The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease, in human serum and plasma specimens.
Categories: FDA News

WinRho SDF Liquid

Wed, 10/18/2017 - 05:49
Updated Package Insert, Patient Information and "Dear Healthcare Provider" Letter with Drug Warning Information. Updated: January 26, 2010.
Categories: FDA News

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff

Fri, 10/13/2017 - 14:13
This is a Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff
Categories: FDA News

Anti-B (Murine Monoclonal)

Tue, 10/10/2017 - 07:27
Categories: FDA News

Procleix West Nile Virus (WNV) Assay

Tue, 10/10/2017 - 06:38
Categories: FDA News

COBAS TaqScreen West Nile Virus Test

Tue, 10/10/2017 - 06:31
Categories: FDA News

SOPP 8406: CBER Processing of PDUFA Application Payments

Fri, 09/29/2017 - 11:11
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.
Categories: FDA News