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Comment Examples

Request for Information (RFI)*


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* We selected these examples to provide a range of perspectives and approaches used in Federal Comments. Their inclusion here does not indicate DiMe’s endorsement.

Our submitted comments

Building Trust In the Health Data Ecosystem

Executive Director Jen Goldsack asserts that in order to ensure the success of Cures 2.0, provisions must be added that bolster public trust in how health data are used.

July 2020

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Letter to Congress urging action on telehealth

DiMe urges action from congress to make telehealth flexibilities created during the COVID-19 pandemic permanent

June 29th, 2020

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Modernizing FDA’s Data Strategy

The FDA acknowledges that a large gap separates important scientific advances and the technologies needed to translate those advances into new therapies for patients and new ways to protect the public health. DiMe comments on how the evidence base for the safety and effectiveness of these new products has not kept pace with their development.

April 30th, 2020

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Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency

The FDA issued a guidance to leverage non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic. DiMe provided a public comment.

April 14th, 2020

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FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

This FDA guidance provides general considerations to assurance the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during COVID-19.

April 21st, 2020

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2020-2025 Federal Health IT Strategic Plan

The Department of Health and Human Services, led by the Office of the National Coordinator for Health Information Technology (ONC), released the draft 2020-2025 Federal Health IT Strategic Plan (plan) for public comment.

March 31, 2020

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Congress seeks input on Cures 2.0

U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released their initial vision for their landmark Cures 2.0 legislation and called on experts and stakeholders to submit their ideas and feedback on the plan.

December 16, 2019

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Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making

The FDA hosted a public workshop to convene a discussion on incorporating clinical outcome assessments (COAs) into endpoints for regulatory decision making. There was a subsequent comment period.

February 4, 2020

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21st Century Cures: Establishment of the BEST Resource Taxonomy

The FDA established a public docket to receive comments from interested parties on the Agency’s publication of a glossary of terms which is part of the BEST (Biomarkers, EndpointS, and other Tools) Resource Taxonomy.

September 23, 2019

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