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Approved Risk Evaluation and Mitigation Strategies (REMS)


Shared System REMS
REMS last update:

What is the purpose of the REMS?

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Assessment Plan
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
07/01/2019
07/10/2018 Revised to correct a typographical error.
05/15/2018 Modified REMS materials to reflect expansion of the PrEP indication to include the adolescent patient population based on the revisions to the indication.
12/08/2017 Modified to change the graphics for the SSS REMS educational materials, including a change in color scheme and removal of Truvada brand elements.
09/21/2017 Revised to correct a typographical error (s).
06/08/2017 Modified to establish a Single Shared System (SSS) REMS for the elements to assure safe use required for the reference listed drug (RLD) Truvada and ANDAs referencing Truvada, called the emtricitabine/tenofovir disoproxil fumarate REMS Program, which will become applicable on the date of full approval of the first ANDA referencing Truvada. The modification being approved results in a two-part REMS consisting of: (1) the requirements previously approved Truvada REMS; and (2) the new single, shared system for emtricitabine/tenofovir disoproxil fumarate products. The requirements of the previously approved Truvada REMS will remain applicable until full approval of the first ANDA, at which time, they will automatically be replaced by the requirements of the single, shared system.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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