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Documents recently posted on the CBER Web Site

Last Build Date: Tue, 03 Mar 2009 18:14:00 -0500



Fri, 28 Apr 2017 11:21:00 -0400

Package Insert Updated December 2009 to include additional adverse events.


Fri, 28 Apr 2017 10:35:00 -0400


Thu, 27 Apr 2017 11:01:00 -0400

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

Fri, 21 Apr 2017 11:39:00 -0400

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding blood, blood components or blood products. Both licensed and unlicensed blood establishments must submit requests for an exception or alternative procedure to the requirements in Parts 600-680.

Clinical Investigator Status (Biologics)

Thu, 20 Apr 2017 12:29:00 -0400

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

Complete List of Substantially Equivalent 510(k) Device Applications

Mon, 10 Apr 2017 15:00:00 -0400

Information updated through March 31, 2017