September 2009
Proactive Preparation of Defense of Post-Recall LitigationBy Lori Cohen and Christiana C. Jacxsens
After a pharmaceutical or medical device manufacturer initiates a recall, its duties pursuant to FDA laws and guidelines do not end there. The FDA has set out certain responsibilities and steps that a manufacturer must or should follow after initiating a recall. Pharmaceutical and medical device manufacturers, however, can effectively combine their post-recall duties and responsibilities with a proactive preparation of a defense of potential litigation.
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