NCHR Public Comment Regarding Device Trial Participation Snapshots

January 13, 2025: In response to FDA’s draft of medical device Snapshots, NCHR urged FDA to add more information about risks and benefits in wording that is easy to understand. The information should also quantify the risks and benefits and explain the implications of the strengths and weaknesses of the evidence. The SnapShots should be brief but should include the information that helps patients and physicians make important decisions about whether the device has benefits that outweigh the risks for patients.

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Testimony of Dr. Zuckerman at FDA Joint Advisory Committees Meeting on Clozapine REMS for Neutropenia

November 19, 2024: We testified at the FDA Advisory Committees joint meeting that the REMS to prevent neutropenia in Clozapine patients is essential to save lives, but that some barriers to patient access should be reduced. Clozapine can cause a dangerous reduction in an important type of white blood cells, making patients vulnerable to infections that require hospitalization and can be fatal.

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Statement of Dr. Diana Zuckerman At the FDA General and Plastic Surgery Devices Advisory Panel on ProSense Cryoablation System

November 7, 2024: We testified at an FDA Advisory Panel meeting to advise FDA whether ProSense Cryoablation can replace lumpectomy for older women with very early, low-risk breast cancer. This technique can freeze and destroy a tumor in a few minutes but the research was not well-designed to determine if it is as safe as lumpectomy, and if so, for which types of patients.

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