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The Web site of the US Food and Drug Administration ( The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of six product centers, one research center, and two offices.  FDA is responsible for ... Full Bio
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Summary Basis for Regulatory Action - ALPROLIX

 Summary Basis for Regulatory Action Date 28 March 2014 From Nancy Kirschbaum, PhD, Committee...

Class I Medical Device Recall: Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System with Version 2.0 Software - Software

Spacelabs Healthcare is recalling the ARKON Anesthesia System with Version 2.0 Software due to a software defect. This software issue may cause...

Federal Register: Proposed Strategy and Recommendations for a Risk-Based Framework for Food and Drug Administration Safety and I

The FDA is announcing the following public workshop entitled "Proposed Strategy and Recommendations for a Risk-Based Framework for Food and Drug...

Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials - Draft Guidance for Institutional Review

The purpose of this document is to provide draft guidance on important information that should be provided in an original investigational device...

Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Draft Guidance for Industry and Food and Drug

This guidance document was developed to notify manufacturers of the recommended endotoxin limit for the release of intraocular devices and...

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Aminata wrote on FDA's Whiteboard. Mar 15 2013
jessica044 wrote on FDA's Whiteboard. Oct 24 2012
FDA updated their profile. May 25 2010
FDA updated their profile. May 25 2010
FDA joined the Children's Health Community. May 25 2010
FDA's Whiteboard
Mar 15 2013 by Aminata
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Oct 24 2012 by jessica044
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