December 27, 2022: We address suggestions of how to improve this guidance to promote safety and efficacy in clinical investigations of medical products involving children. Many new medical products that are used by children are never actually tested on them or approved for them prior to entering the market. Many children are either left with no treatment options or given products “off label” that have not been tested for safety, effectiveness, or dosage requirements in patients of their age, size, or weight.
Read More »Author: Caroline Bradford
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 Testifies Before Cardiovascular and Renal Drugs Advisory Committee on Heart Failure Drug
Dr. Ealena Callender of National Center for Health Research tells Dec. 2022 FDA Advisory Committee to require better research on OM heart failure drug due to lack of evidence of efficacy and concerns about safety due to toxicity.
Read More »ALS patients contend with $158K price tag on new drug
AP, December 18, 2022: Patients with ALS (also called Lou Gehrig’s disease) celebrated when FDA approved Relyvrio in 2022. But it costs $158k despite combining two old ingredients, the benefits are unclear, and the effective ingredient may be the one sold by Amazon for $1/day. Important research is underway to find out if the ingredient available on Amazon is equally or more effective, says Dr. Diana Zuckerman of National Center for Health Research.
Read More »Fitness Tracking Apps and Eating Disorders
Belinda Gorsuch, National Center for Health Research December 15, 2022 It seems there is an app for everything. About 69% of adults track health indicators, such as steps, calories, and hydration [1]. But, has fitness tracking technology gone too far? Some believe our phones can help us improve our diet and exercise routines. Others claim […]
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