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.
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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.
Read More »NCHR Testimony at FDA Advisory Panel on Wound Dressings
October 26, 2022: Dr. Diana Zuckerman testified at the FDA Advisory Meeting on Wound Dressings. She pointed out that data on safety and effectiveness is lacking for these products even though they have been used for decades. Thousands of adverse event reports to FDA indicate contamination and problems with sterile packaging. FDA should classify them as Class III and require clinical trials and inspections.
Read More »NCHR testifies for FDA Advisory Committee about withdrawing approval of Makena, to prevent preterm birth
October 17, 2022: In OB/GYN, preterm delivery is one of our most difficult challenges. The causes are complicated and not well-understood. But the associated harms are clear and devastating. We all want an effective intervention that will reduce the number of babies delivered too early and lead to better maternal and fetal outcomes. Unfortunately, current data do not indicate that Makena is the solution we have been seeking.
Read More »Comments of National Center for Health Research The USPSTF Draft Evidence Review: Screening for Anxiety in Adults
October 17, 2022: We are concerned the USPSTF recommended anxiety screening does not have enough supporting evidence, and the resulting treatments come with serious risks.
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