November 7, 2023: Blood irradiator devices have been used for decades on cancer patients to try to prevent metastasis. NCHR agrees with FDA there is no evidence that they benefit patients and it is clear the radiation can be harmful. At an FDA Advisory Committee meeting in November 2023, we urged FDA to finally require scientific studies if companies want to continue to sell these devices.
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NCHR’s Comments on Proposed Supplemental Guidance for CPSC Chronic Hazard Guidelines
NCHR criticizes CPSC’s revised proposal for chronic hazard guidelines for focusing on linear modeling that is not appropriate for endocrine disrupting chemical and for including a loophole that enables companies to do whatever they think is scientifically appropriate. We urge the CPSC to produce more explicit, rigorous guidelines based on sound science, since that is essential for the safety of consumers.
Read More »NCHR Comments on FDA’s Draft Guidance on QTc Information in Human Prescription Drug and Biological Product Labeling
October 10, 2023, in response to FDA’s draft guidance on QTc product labeling to
correctly measure heartbeat contraction and relaxation, NCHR recommends that FDA specify a preferred method of calculating the QTc, provide methods for to improve
study design, and require studies of the impact of drug-drug and
drug-disease interactions. These changes to the guidance are needed to encourage industry to do the research needed to ensure the safety and effectiveness of their products.
NCHR Comment on CPSC’s Proposed Study of Toddlers Using Smart Toys
October 6, 2023: The Consumer Product Safety Commission is responsible for ensuring that consumer products are safe. One of their jobs is to make sure toys are labeled to indicate the age of children for which they are safe and age-appropriate. In October 2023, NCHR reviewed a proposed CPSC study of new toys intended for ages 2-4 and expressed concerns that there were too few children in the proposed study to provide reliable, generalizable information about the use and safety of these toys for a diverse group of U.S. children.
Read More »Dr. Diana Zuckerman’s Testimony at the FDA Advisory Committee on NurOwn for ALS Treatment
September 27, 2023: NCHR’s Diana Zuckerman’s testified at FDA’s Advisory Committee meeting on September 27, 2023 about tripling of deaths and no benefits of NurOwn treatment for ALS. Improvements were identical for placebo compared to NurOwn treatment, and patients should not have to pay for unproven treatment. Experimental treatment should be free through clinical trials or expanded access.
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