FDA Guidance on REMS Changes Explained

Three Drinker Biddle & Reath attorneys say a 7/9 FDA final guidance, Risk Evaluation and Mitigation Strategies: Modifications and Revisions, demonstrates the importance of classification. Writing online in the National Law Review, the three say that even though the categories lend themselves to a certain level of intuitiveness, “it is imperative to consult the FDA final guidance and seek advice from FDA ‘in accordance with established FDA procedures’ if need be. Otherwise, the misclassification of proposed changes would delay the distribution of potentially helpful information.”

The guidance gives information on changes to approved REMS, the application process for proposed REMS changes, and how the agency will process submissions. The article covers: categories of REMS changes, REMS revisions, REMS modifications, and adequate rationale for REMS modifications.