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 »Author: Caroline Bradford
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.
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 »A Special Report: Can Breast Implants Cause Chronic Disease?
HealthCentral, October 25, 2022: This excellent review from HealthCentral.com quotes breast implant patients, NCHR and other experts responding to new FDA warnings and troubling research. We explain the research evidence of risks of breast implant illness and lymphoma and point out the misleading denials of risk by plastic surgeons.
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