November, 2023, NCHR supports HHS’ proposed healthy people 2030 objectives and the inclusion of social determinants of health as key measurable objectives. To strengthen HHS’ goal of improving community health and achieving health equity, we recommended including individual and organizational health literacy objectives and forming inclusive, diverse stakeholder committees.
Read More »Author: Caroline Bradford
NCHR Provides Oral Testimony at the FDA Pulmonary Allergy Advisory Committee Meeting on Gefapixant
November 17, 2023: NCHR provided testimony at the FDA Pulmonary Allergy Advisory Committee Meeting on a new treatment for refractory or unexplained cough, Gefapixant. We reviewed the research which showed Gefapixant had a modest difference in cough frequency (<1%) and improved quality of life (1 point reduction) when compared to placebo, a small reduction that is of little value to patients. One third of patients also reported an adverse taste-related event with Gefapixant. We concluded that Gefapixant does not adequately address the unmet need for treating patients with refractory or unexplained cough in terms of effectiveness or tolerability.
Read More »FDA’s Janet Woodcock to retire early next year
STAT News, November 16, 2023: Principal Deputy FDA Commissioner Janet Woodcock will retire from the FDA in early 2024 after almost 40 years at the agency, many as a powerful and controversial leader. We explain how her legacy has tarnished the FDA’s reputation.
Read More »NCHR testimony at the FDA Oncologic Drugs Advisory Committee meeting regarding the dangling accelerated approvals of pralatrexate and belinostat for peripheral T-cell lymphoma
November 16, 2023: We believe it necessary for FDA to rescind approval until a trial is completed that confirms meaningful clinical benefits
Read More »Testimony of Diana Zuckerman at FDA Advisory Panel on Blood Irradiators
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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