FDA Takes Steps to Standardize REMS Info

FDA Takes Steps to Make REMS Info Easier to Share

FDA is launching a pilot project to integrate Risk Evaluation and Mitigation Strategies (REMS) into Structured Product Label (SPL) format. This will facilitate the sharing of documents and ease the integration of critical information into pharmacy and hospital IT systems.

As with most pilot programs, participation is on a voluntary basis, and open to application holders of drugs with REMS. With the program, FDA intends to “evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format.”

FDA is accepting requests from candidates that meet the qualifications and are interested in participating until December 7, 2015. The program will last for four months, and will take place from October 6, 2015 to February 3, 2016. For more details on the program or how to register, see the announcement in the Federal Register, here.

This pilot program is one of FDA’s four “priority projects,” which were introduced in a July 2013 meeting in an attempt to improve the REMS program.