BRIEF—New REMS webpages launched by FDA

The US Food and Drug Administration is launching a new set of web pages that aims to provide a one-stop source for general information about Risk Evaluation and Mitigation Strategy (REMS) programs.

These webpages organize general REMS information according to audience (ie, patients, health care professionals and industry) and most pages are presented in a short question and answer format. 

In 2007, the Food, Drug Administration Amendments Act gave FDA the authority to require a REMS when the FDA determines it is necessary to ensure the benefits of the drug outweigh the risks.

Over the past decade, REMS have enabled the FDA to approve drugs that otherwise might not have been approvable. However, REMS can also place a burden on the healthcare delivery system.

One piece of valuable feedback the FDA has received regarding REMS is that information on drug-specific REMS, and on REMS more generally, can be difficult to locate on the web.

REMS information will now be easier to find, relevant and ultimately more useful because organization of the new web content is based on the role a person might have in a REMS program.

Also, other newly-created pages guide visitors to current information about REMS programs, FDA guidances, public meetings, and educational resources.