How to Respond to Consent Decrees

01 May 2012 BioPharm International Publication
Authors: David L. Rosen

BioPharm International

Partner David Rosen provides an overview of the Food and Drug Administration’s increasing use of consent decrees as compliance enforcement tools, stating that companies can potentially improve their manufacturing operations and systems quality by efficiently meeting the terms and conditions of a consent decree. He adds that entering into a consent decree requires significant time and resources, but notes that companies can better meet these requirements by proactively investing in a comprehensive quality program.

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