NCHR Comments on FDA’s Draft Guidance on QTc Information in Human Prescription Drug and Biological Product Labeling

October 10, 2023, in response to FDA’s draft guidance on QTc product labeling to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.

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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.

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NCHR Comments On FDA’s Requirements for Tobacco Product Manufacturing Practices

October 6, 2023, in response to FDA’s draft guidance on tobacco manufacturing practices, NCHR recommends that the FDA requires manufacturers to accurately reflect the nicotine concentration of their products using clear labeling, restrict flavor additives, and impose maximum nicotine levels. We also urge FDA to exercise its full authority for manufacturer violations to improve incentive for compliance.

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