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FDA Provides Access to Certain REMS Drugs

New guidance allows sponsors and healthcare providers discretion regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing

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By: Kristin Brooks

Managing Editor, Contract Pharma

As part of the U.S. FDA’s efforts to address the coronavirus pandemic, the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time. For drugs subject to REMS with lab testing or imaging requirements, healthcare providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests or studies during this public health e...

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