FDA eases medication guide distribution requirements

Traynor, Kate
April 2011
American Journal of Health-System Pharmacy;4/15/2011, Vol. 68 Issue 8, p649
Academic Journal
The article discusses the draft guidance document from the U.S. Food and Drug Administration (FDA) relaxing the agency's stance on the need to distribute medication guides to inpatients which used to be a part of the product's risk evaluation and mitigation strategy (REMS). An overview of possible implications of FDA's enforcement discretion on the provider and the manufacturer is offered. The article suggests that while the providers are happy, it is a setback for the manufacturers of products that have medication guides.


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