October 10, 2023, in response to FDA’s draft guidance on QTc product labeling to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.
We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
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 »NCHR Comments on the Proposed Data Collection Submitted for Public Comment and Recommendations for Thermal Spray Coating
October 6th, 2023, in response to CDC’s draft guidance on information collection regarding thermal spray coating, NCHR recommends that the CDC improves the language of the survey questions to enhance study design and better inform occupational health standards.
Read More »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.
Read More »NCHR Comments on the FDA Draft Guidance for Industry Concerning Dietary Guidance Statements in Food Labeling
September 25, 2023: NCHR supported the use of Dietary Guidance Statements to reduce nutrition-related chronic diseases and advance health equity. We made recommendations regarding dietary statements for products that exceed recommended amounts, or contain fruit juice, whole grains, and alcohol.
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