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.
Read More »On Medical Treatments & Products
December 12, 2024: Testimony of Dr. Siddiqui at FDA Vaccines and Related Biological Products Advisory Committee Meeting
December 12, 2024: NCHR Postdoctoral fellow Dr. Saman Siddiqui testified at the FDA Advisory Committee meeting about the need for better clinical trials of RSV vaccines for infants and toddlers because of serious risks in that age group.
Read More »Testimony of Dr. Diana Zuckerman at the FDA Joint Advisory Committee 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.
Read More »Testimony 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.
Read More »Testimony of Dr. Diana Zuckerman at the FDA Gastrointestinal Drugs Advisory Committee Meeting on Ocaliva
September 13, 2024: NCHR’s Dr. Diana Zuckerman tells FDA Advisory Committee that the data presented on Ocaliva for a rare liver disease does not meet the FDA’s standard of evidence to keep it on the market and that the results do not prove that OCA prevents death or prevents the need for a liver transplant.
Read More »