martes, 30 de enero de 2018

Risk Evaluation and Mitigation Strategies (REMS)

Risk Evaluation and Mitigation Strategies (REMS)

The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA

Today the U.S. Food and Drug Administration (FDA) is launching a new set of webpages 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 (i.e., 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 FDA determines it is necessary to ensure the benefits of the drug outweigh the risks. Over the past decade, REMS have enabled 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 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.
Our goal is to enable easier compliance with these programs so that patient access to drugs with REMS can be maintained, while still preserving their safe use.

As always, FDA welcomes feedback. Please use the Contact REMS Form to send us any comments you have on the newly created REMS webpages. 

For more information, please visit: New REMS Webpages.

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