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  5. Transcript: REMS@FDA Tutorial (June 2016)
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Transcript: REMS@FDA Tutorial (June 2016)

Transcript: REMS@FDA Tutorial (June 2016)

Host: Captain Catherine Chew
Pharmacist: Lieutenant Commander Lindsay Wagner

CAPT Chew: 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.

LCDR Wagner: 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.

CAPT Chew: 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.

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