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10/7/2015

ASHP Recommends Greater Clarity and Consistency in FDA Communications on REMS

The Food and Drug Administration (FDA) could alleviate some of the communications challenges associated with REMS through targeted outreach to healthcare providers, ASHP told an agency panel yesterday.

ASHP spoke at a hearing called by the FDA in an attempt to understand the impact of the use of REMS on the healthcare system and to identify improved approaches for minimizing their burden on patients and providers.

ASHP encouraged FDA officials to work toward a centralized electronic means for all REMS, including registration, provider education, and patient documentation requirements. Click here to view the statement submitted by ASHP.

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