October 3, 2022: NCHR’s National Long COVID conference was held in Washington, DC. Topics included autoimmunity, ME/CFS, Caregiving, Children and Teens, Dept of Veterans Affairs, and Research.
Read More »Author: Caroline Bradford
NCHR criticism of drug for chronic kidney disease at FDA Advisory Committee Meeting
November 16, 2022: Elevated phosphorus is a serious complication encountered by the majority of patients with chronic kidney disease on dialysis. Tenapanor represents a novel approach to this major problem. Still, we are concerned about this product because the data do not show it to be more effective than current options, and the significant side effects may lead to poor patient compliance.
Read More »NCHR Comments On Emergency Authorization for New COVID-19 Drug
November 9, 2022: FDA Advisory committee considers EUA emergency authorization of new COVID-19 treatment. NCHR says study is small and flawed and additional data are needed and FDA advisors agree.
Read More »A Tiny Lab Finds Danger on Drugstore Shelves While the FDA Lags Behind
Bloomberg News, November 9, 2022: Valisure is a small lab that found carcinogens in Zantac, sunscreen, shampoo, sanitizers, and other products. NCHR asks: Why isn’t FDA doing these routine impurity tests? Too cozy with industry?
Read More »Testimony of Dr. Diana Zuckerman About I-omburtamab FDA Advisory Committee Meeting
October 28, 2022: Dr. Diana Zuckerman testified at the FDA Advisory Meeting on I-omburtamab, a drug for children’s brain cancer (relapsed neuroblastoma). She agreed with the FDA that the company’s studies had no adequate control group, making it impossible to determine if the treatment worked better than placebo. Therefore, despite the urgent unmet need, the drug does not meet the required standard of evidence for FDA approval. We hope the company will make the drug available for free through the FDA’s Expanded Access program for experimental drugs.
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