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Legal staff on both sides of a medical product damage claim lawsuit must understand the collection and analysis of the safety data used to prepare the warning section of the product’s label. Regardless of whether you’re representing the plaintiff or defendant, you should be familiar with the process (and resulting documentation) FDA requires manufacturers to use in establishing evidence of a product’s safety.
On November 16, 2017 Dr. Joshua Sharlin offered a 45-minute presentation to provide an insider’s view of common problems and errors in adverse event reporting. In this Document of the Week, learn more about some of the important points he made in this excerpt from the slides.
Featured until November 27. Click here to download.