FDA What's New: Vaccines, Blood & Biologics

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Documents recently posted on the CBER Web Site
Updated: 22 min 17 sec ago

BabyBIG

Tue, 08/08/2017 - 13:56

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

Fri, 07/28/2017 - 08:26
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)

Tue, 07/18/2017 - 06:38
Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

FluLaval Quadrivalent

Thu, 07/13/2017 - 14:12

EVARREST (Fibrin Sealant Patch)

Wed, 07/05/2017 - 14:50

Biologics Guidances

Mon, 07/03/2017 - 11:48

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2017

Mon, 07/03/2017 - 11:15
Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2017.

ABBOTT HIVAB HIV-1/HIV-2 (rDNA) EIA

Mon, 06/05/2017 - 12:36
HIVAB HIV-1/HIV-2 (rDNA) EIA is an in vitro enzyme immunoassay for the qualitative detection of antibodies to human immunodeficiency viruses type 1 and/or type 2 (HIV-1/HIV-2) in human serum, plasma, or cadaveric serum

COBAS TaqScreen West Nile Virus Test

Mon, 06/05/2017 - 11:46

Procleix West Nile Virus (WNV) Assay

Mon, 06/05/2017 - 11:34

Auszyme Monoclonal

Mon, 06/05/2017 - 11:32
CBER Auszyme Monoclonal Product Approval Information

Procleix HIV-1/HCV Assay

Mon, 06/05/2017 - 11:27

ORTHO T. cruzi ELISA Test System

Mon, 06/05/2017 - 10:42

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

Wed, 05/31/2017 - 12:32
Vaccine lot release information updated on 3/3/2010.