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.

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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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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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