> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Posts REMS Changes Summary
- URL: https://www.fdaweb.com/fda-posts-rems-changes-summary/
- Published: 2019-05-02T12:00:00.000Z
- Updated: 2026-09-15T01:24:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144008

FDA has posted a summary of changes made in March and April to 17 risk evaluation and mitigation strategies (REMS). The [listings](http://s2027422842.t.en25.com/e/es?s=2027422842&e=210932&elqTrackId=78D8A052C380BCBFF284D754BEBE9730&elq=d2b989b779aa4e05847259f3dd0fd34a&elqaid=7856&elqat=1&ref=fdaweb.com) include approval of REMS for four testosterone NDAs, establishment of a shared system REMS for mifepristone, and an additional NDA added to the opioid analgesic shared system.