FDA Unveils Updated REMS Website

Drugmakers and patients can now access risk evaluation and mitigation strategies for FDA-approved drugs, thanks to an updated website launched by the FDA last week.

The new site, REMS@FDA, allows users to download data files in Excel spreadsheets on:

• All approved REMS, including those no longer in place;
• All modifications and revisions to each REMS program; and
• All materials that have been part of REMS.

The site also allows users to filter information through a search function.

The previous REMS website, which did not allow any downloading, will remain active until July 13, when it will be archived. Access the new site at www.accessdata.fda.gov/scripts/cder/rems/index.cfm. — John Bechtel