The US FDA can now require companies to develop a risk evaluation and mitigation strategy (REMS) for therapeutic products. Bethan Hughes investigates the recent evolution of risk-management strategies in drug development.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 12 print issues and online access
$259.00 per year
only $21.58 per issue
Buy this article
- Purchase on SpringerLink
- Instant access to the full article PDF.
USD 39.95
Prices may be subject to local taxes which are calculated during checkout
Rights and permissions
About this article
Cite this article
Anticipating REMS. Nat Rev Drug Discov 7, 963 (2008). https://doi.org/10.1038/nrd2776
Issue date:
DOI: https://doi.org/10.1038/nrd2776
This article is cited by
-
The Gap Between Clinical Trials and Clinical Practice: The Use of Pragmatic Clinical Trials to Inform Regulatory Decision Making
Clinical Pharmacology & Therapeutics (2010)
-
2008 FDA drug approvals
Nature Reviews Drug Discovery (2009)
-
News in brief
Nature Reviews Drug Discovery (2009)
-
2008 in reflection
Nature Reviews Drug Discovery (2009)