The FDA has overhauled its Risk Evaluation and Mitigation Strategies (REMS) website to make it easier to find up-to-date information. The new version moves details of whether REMS apply to a drug, what components are in place and when they were last updated to the forefront, ending the need for users to dig through a database to find information.
The regulator shared details of the update in an email to the trade press, in which it said the changes were shaped by user feedback. Visitors to the website are now greeted by an alphabetically ordered list of drugs to which REMS apply, the date on which the documents were last updated and details of which specific approaches--such as Medication Guides and Elements to Assure Safe Use--are in place. Users can click through to find the full documents and search for specific active ingredients or REMS names.
As Alexander Gaffney notes in Regulatory Focus, the new look and features such as the ability to order the REMS by the date on which the documents were last changed represent notable upgrades over the cumbersome old system. The FDA hopes the changes will make it easier for people to compare the requirements across REMS. In doing so, FDA is aiming to lessen the confusion organizations face when trying to comply with multiple REMS programs. The regulator is also hosting a webinar on June 23 to explain the REMS website to healthcare professionals and students.
The push to improve the REMS website arrives at a time in which FDA is revising the ways the industry can access many of its resources, notably the data it has made available through the openFDA initiative. While openFDA, the REMS update and improvements to other areas such as the drug shortages database are distinct, separate projects, all are shaped by a desire to make it easier for people to access information held by the regulator, a task that has been a source of frustration for users in the past.
- read Regulatory Focus' article
- check out the REMS website