FDA Due Diligence – An Ounce of Prevention...

Date: Nov 08, 2010

A crucial part of any business transaction is the due diligence conducted by the prospective purchaser to evaluate the deal and identify the potential liabilities it might be assuming.  Virtually no buyer would skip an assessment of the corporate structure, tax status, intellectual property portfolio, or ongoing litigation. 

For companies regulated by the U.S. Food and Drug Administration (FDA) (such as manufacturers of food, drugs, cosmetics, dietary
supplements, and medical devices), one would expect that ensuring compliance with FDA requirements would be a high priority. 
Surprisingly, however, FDA due diligence is often something that is
overlooked or that purchasers decide to do "after the deal."  For a variety of reasons, this is a strategy that can be costly and have significant legal consequences.

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Downloadable Files:
Regulatory Matters! Critical Regulatory Issues to Consider in a Non-Regulatory Setting