July 25, 2024: At the FDA Advisory Committee meeting on a new indication for Imfinzi (durvalumab), NCHR pointed out that the AEGEAN clinical trial did not assess if Imfinzi is necessary both before and after lung tumor surgery. We strongly support the FDA scientists who stated that the trials need to be redesigned to determine whether Imfinzi both before and after surgery is more beneficial compared to Imfinzi either before or after surgery.
Read More »Author: NCHR Intern
Can Children Get Exercise Through Video Games? (“Exergaming”?)
Explore whether exergaming provides adequate exercise for children. Researchers suggest that exergames should be used as a supplement to more traditional forms of physical activity, rather than a replacement.
Read More »NCHR Public Comment on Communications From Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved Medical Products
December 26, 2023: We responded to the FDA’s request for public comment about the scientific information (SIUU) that firms can provide to healthcare providers about the unapproved uses of approved medical products. Promotion for unapproved (off label) uses were prohibited years ago, but that has been loosened over the decades and the FDA’s new draft guidance is worrisome because it is not as specific as it should be about how to ensure that the information the companies provide is accurate and not misleading. We agree with some of the guidance but urge more careful wording to ban the use of poor quality data and misinterpretation.
Read More »Questions remain about new drug for hot flashes
Leaps. Org, Jul 27, 2023: This news story discusses the May, 2023, FDA approval of fezolinetant (brand name Veozah™) to treat hot flashes caused by menopause. While the drug was shown to slightly reduce the frequency and severity of hot flashes per day, NCHR and other experts question if these changes are sufficient to justify any risks and the high cost. We also suggest possible alternative strategies to deal with hot flashes.
Read More »The real costs of the new Alzheimer’s drug, Leqembi — and why taxpayers will foot much of the bill
KFF Health News/CBS News, Aug 1, 2023: CBS News says that the drug Leqembi for mild cognitive impairment and early Alzheimer’s is likely to cost taxpayers billions of dollars. We are among the policy experts who tell Medicare that all registry data need to be public to see if it is safe or effective. Will that happen?
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