FDA's New Generic Drug Safety Labeling Rule


FDA's Generic Drug Safety Labeling Rule

Your office, Dec. 9, 2013


Meet your instructors

Regulatory expert Daniel Kracov, who heads the FDA and healthcare practice at Arnold & Porter will dissect the 54-page rule and explain what the FDA is proposing and how generic firms should proceed with requesting updates to their labels. He’ll also highlight areas within the proposed rule that are unique and potentially confusing and provide advice on how generics and brand manufacturers should proceed. In addition, he’ll provide scenarios regarding when labels could be changed and when they should take the same. He’ll describe the responsibilities of the both the brand and generic manufacturers and the regulatory requirements and risk each face in light of the rule.

Dan Pariser, a recognized expert in product liability law, and a partner in Arnold & Porter LLP's Washington, DC office, will focus on the product liability implications of the new rule. Mr. Pariser will discuss the potential surge in liability cases, how to prepare and defend against these cases. Plus, he will examine how generics firms that fail to develop comprehensible pharmacovigilance programs will be inviting very significant liability.