FDA may require a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that the benefits
of certain drugs outweigh their risks. In June 2015, FDA launched a new and improved
REMS website called REMS@FDA.
Hi, I’m Captain Catherine Chew, and this is Drug Info Rounds, brought to you by the
pharmacists in FDA’s Division of Drug Information.
The new REMS@FDA website improves the organization of REMS information online. This makes it
easier for users to access comprehensive REMS information. Lieutenant Commander Lindsay
Wagner will lead us through a tour of the new website.
Type www.fda.gov/rems, and you’ll arrive at the new site. On the homepage you’ll
see a searchable and sortable table of current REMS programs. You can search by the name
of the REMS, an element of the REMS program, or by an active ingredient with a REMS.
After you select a REMS, you’ll see the application number, the application holder,
and for REMS that cover multiple products, you’ll be shown what products are covered
by that REMS and the date the product was added to the REMS. The site features links
to the prescribing information from the DailyMed site and to the Drugs@FDA information for
a product.
Further down the REMS page, you will see “What do participants need to know?” This next
section is just for you! Here we tell healthcare providers and pharmacists what you need to
know. You can also find a link to the application holder’s website.
Depending on the requirements of the REMS, the information that appears will be different.
It is now easier than ever to quickly see what is required to prescribe a drug with
an approved REMS or to dispense it to a patient.
Scroll further, and you’ll find links to REMS materials, including full REMS documents,
patient counseling information, training materials, and other documents.
Another useful feature of this website is access to the Data Files. Here we provide
all of the REMS data, including REMS that are no longer in place. A data dictionary
is provided for users.
We’re interested in hearing what you think about the REMS@FDA website. Click the Contact
Us link to share your thoughts. If you have questions about REMS@FDA, call or email FDA’s
Division of Drug Information.