Practice Tip: FDA Issues Draft Guidance for REMS

AGG attorneys Alan G. Minsk and Lanchi Nguyen published “Practice Tip: FDA Issues Draft Guidance for REMS,” in Product Liability Law & Strategy, a publication of Law Journal Newsletters. On September 30, 2009, the Food and Drug Administration (FDA) issued a draft guidance for the industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics. The article is part one of a two-part series, with the second part running in the April issue. To read the full article, please click here (subscription or purchase required to view).