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Do you know how to navigate the FDA's website when searching for FDA warning letter information?

Jul 12, 2011 | Free Downloads | email | Print

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FDA Warning Letters: How to Navigate FDA's Website

by Carl Anderson, Regulatory Affairs and Quality Assurance Consultant

Editor's Note: Carl Anderson recently attended the Global Conference for the Association of Clinical Research Professionals (ACRP) in Seattle, Washington. He shared some of his conference observations in his blog, GxP Perspectives, and with GxP Lifeline.

During the (ACRP) conference it became apparent that many people, including FDA employees, have a difficult time searching for Warning Letters on FDA's website. The Warning Letter section is an absolute mess. So I thought I would provide a few simple search tips to help find Warning Letters for GCPs. Unfortunately cGMP Warning Letters are more difficult but the tips still help.

When searching for FDA Warning Letters, scroll down and choose to "Browse Warning Letters by SUBJECT." You will be presented with the alphabet. Click on "C" and then scroll down past all the "cGMP" categories until you reach "Clinical Investigator" where you will find the majority of GCP Warning Letters.

They will be listed in alphabetical order. There is a "Sort by:" option. Choose "Letter issued DESC" from the dropdown menu. You will then have most of the GCP Warning Letters with the most recent listed first. You can also choose as subjects: Clinical Investigator - Sponsor; Bioresearch Monitoring; IRBs; Sponsor Obligations; and "IDE..." for medical device Warning Letters. There are several ways of listing for each category. You can sort by "Letter Issued DESC" for each category. There are five GLP categories plus Good Laboratory Practices. Go figure.

Carl Anderson is a Tacoma, Washington-based regulatory affairs and quality assurance consultant in the field of FDA health product approvals including drugs, biologics, and medical devices. From 1987 to 2005 he worked for the United States Food and Drug Administration. In 1994 he began conducting inspections in the Bioresearch Monitoring program and inspected clinical investigators, institutional review boards, nonclinical laboratories, and sponsors of clinical research.

Anderson has made frequent public presentations on good clinical practice, quality assurance, and FDA regulations to professional and industry organizations including the Society of Quality Assurance, Drug Information Association, Regulatory Affairs Professional Society, and Association for Clinical Research Professionals. He also conducts training for private industry as well as public agencies such as the Centers for Disease Control and Prevention (CDC) and university extension services.Anderson may be reached by phone at 253-307-6513 or via email at carl11anderson@yahoo.com. Read his blog at http://carl1anderson.wordpress.com/.

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