FDA Reopens Comment Period for Shared System REMS

The FDA reopened the comment period for its draft guidance on the development of a shared system Risk Evaluation and Mitigation Strategy (REMS).

Although the requirement for a single shared REMS system applies only to ANDAs, the FDA said a shared system in other cases could increase efficiencies by covering multiple prescription drug products and allowing two or more applicants to participate in development.

In an Aug. 30 notice, the FDA reopened the comment period on the June 1 draft, allowing 14 more days for comment.