With REMS, what goes up can come down

Thompson, Cheryl A.
May 2011
American Journal of Health-System Pharmacy;5/1/2011, Vol. 68 Issue 9, p783
Academic Journal
The article reports that the Food and Drug Administration (FDA) will alter a risk evaluation and mitigation strategy (REMS) if given evidence that a suspected risk does not exist at all. It highlights the FDA actions of lifting a requirement of monthly liver function tests (LFTs) for Ambrisentan tablets, and eliminating the REMS program altogether for sacrosidase oral solution. The article also includes comments from Timothy Lesar, pharmacy director at the Albany Medical Center in New York.


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