December 27, 2022: NCHR strongly urges the FDA to ban the remaining phthalates from materials that have contact with food, and to rigorously enforce this ban. Phthalates are endocrine disrupting chemicals that have potential adverse effects for children and adults, such as fertility issues and obesity, and can be detrimental even at low levels of exposure. These toxins are found in many items used in food preparation, contact, and packaging, and can leach out of these products where they can be consumed or inhaled.
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NCHR Comments on FDA Updates to the Breakthrough Devices Program to Reduce Disparities in Health Care
December 20, 2022: We disagree with the guidance because of the enormous loophole it represents. Altering the eligibility criteria for the breakthrough pathway to include certain devices that have the “potential” to benefit certain populations is too vague. FDA must Improve the standards of evidence required to authorize Breakthrough medical devices prior to focusing on equity issues.
Read More »NCHR Letter to Senate HELP and House Energy & Commerce Committees Regarding the VALID Act
December 14, 2022: We strongly support the inclusion of the VALID Act in the year-end omnibus spending package. This important bill will provide the FDA with the authority and resources necessary to ensure that the highest-risk diagnostic tests are valid and reliable.
Read More »NCHR’s Comment on Topics Discussed in the Advancing Premarket Safety Analytics Workshop
NCHR had the opportunity to share our views with the Food and Drug Administration (FDA) about topics brought up in the Advancing Premarket Safety Analytics Workshop, including our support of the FDA Medical Queries as we believe it would better quantify adverse events. Additionally, we agree that the FDA should be transparent in providing their methods for the standard safety tables and figures via their integrated guide to the public and urge them to make these guidelines mandatory so that everyone is held to the same standard.
Read More »NCHR’s Comment for the Clinical Laboratory Improvement Advisory Committee
November 7, 2022: NCHR urges CLIAC to amend its Clinical Laboratory Improvement Amendments (CLIA) of 1988 because CLIA needs to better reflect the advancements in science and technology that occurred over the past two decades. Current CLIA standards have numerous limitations and deficiencies that must be addressed. Two examples include the accuracy of lab-developed diagnostic tests and the electronic health records and software prompts used by physicians across the country.
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