October 6, 2023, in response to FDA’s draft guidance on tobacco manufacturing practices, NCHR recommends that the FDA requires manufacturers to accurately reflect the nicotine concentration of their products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 »Author: Caroline Bradford
Consumer and Public Health Groups Support FDA Proposal to Ensure Accuracy of Lab-Developed Medical Tests
September 29, 2023: A coalition of consumer advocacy groups is welcoming a proposed rule released today by the Food and Drug Administration to regulate laboratory-developed tests (LDTs), a category of diagnostic tests developed and used in a single lab.
Read More »NCHR Comments on the FDA Draft Guidance for Industry Concerning Dietary Guidance Statements in Food Labeling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.
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.
Read More »NCHR Comments on the Proposed Framework from Ranking Member Cassidy to Regulate Artificial Intelligence (AI) in Healthcare
September 22, 2023: NCHR urged the need to reform the 510k clearance pathway for AI/machine learning (ML) devices, promote diversity in the data used for AI, and the need to routinely test effectiveness of updated systems, including post market surveillance.
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