FDA’s Updated REMS Revision Guide Doesn’t Address Industry Concerns

FDA updated guidance on Tuesday (July 9) that explains how drug and biologic sponsors should submit modifications to risk mitigation plans, but did not give into a number of suggestions from both the brand and generic drug industries. The latest version of the guidance expands on some information included in the original final guide in 2015 and includes a few more examples of the types of changes and whether they are considered minor or major. In comments submitted to the...