It Doesn’t Necessarily Take a Village, But…: The Necessity of Internal Collaboration When Preparing a REMS Program

William H. Kitchens, Alan G. Minsk and Lanchi Nguyen authored, “It Doesn’t Necessarily Take a Village, But…: The Necessity of Internal Collaboration When Preparing a REMS Program,” which was published in the Global Forum (Vol. 21, Issue 1, February 2010). Risk Evaluation and Mitigation Strategies (REMS) are programs that the Food and Drug Administration (FDA) can require to ensure the safe use of a drug product. This article summarizes the background of REMS, and FDA industry guidance regarding the required content for proposed REMS, to facilitate a better understanding of how to develop and structure effective REMS. Mr. Kitchens, Mr. Minsk and Ms. Nguyen explain that by putting itself in the FDA’s place and anticipating questions in advance, a firm can help minimize possible application review delays and post-market surprise requests from the FDA, thereby making good medical, regulatory and business sense. To read the full article, please click here.