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Re: Request regarding Covid-19, Docket: FDA-2020-D-1106

Dear Dr. Woodcock,

We, the undersigned, respectfully request the U.S. Food and Drug Administration (FDA) reconsider its limitation of the recently released Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency (Docket FDA-2020-D-1106).

The policy waives certain Risk Evaluation and Mitigation Strategies (REMS) requirements – namely laboratory tests and imaging – but not others. The requirements that certain drugs must be dispensed in-person by certain medical professionals provides similar burdens and risks to patients and providers as the waived requirements. Therefore, we request that in-person dispensation requirements, specifically for mifepristone, be included in this policy as temporarily waived.

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