September 9, 2024: NCHR’s Dr. Diana Zuckerman tells FDA Advisory Committee that sulopenem antibiotic is not proven to benefit patients with uncomplicated UTI compared to amoxicillin or Cipro. It should be evaluated in terms of alleviating symptoms, not in terms of bacteria in the urine, and definitely should not be considered a first line treatment.
Read More »On Medical Treatments & Products
Testimony of Grace Drew at the FDA Advisory Committee Meeting on Imfinzi for Resectable Non-Small Cell Lung Cancer
July 25, 2024: At the FDA Advisory Committee meeting on a new indication for Imfinzi (durvalumab), NCHR pointed out that the AEGEAN clinical trial did not assess if Imfinzi is necessary both before and after lung tumor surgery. We strongly support the FDA scientists who stated that the trials need to be redesigned to determine whether Imfinzi both before and after surgery is more beneficial compared to Imfinzi either before or after surgery.
Read More »Patient, Consumer, and Public Health Coalition Public Comment to CMS on Transcatheter Tricuspid Valve Replacement Coverage
July 19, 2024: FDA approval of TTVR was premature and the data are inadequate to support the safety and effectiveness of TTVR for the Medicare population. The Patient, Consumer, and Public Health Coalition urges CMS to conduct a thorough MEDCAC review prior to making a coverage decision.
Read More »Testimony of Dr. Diana Zuckerman at the Tobacco Products Scientific Advisory Committee Meeting on General Snus
June 26, 2024: NCHR testified at the FDA Advisory Committee about the problems with safety data for General Snus smokeless tobacco and questioned whether they deserve to be labeled as safer than cigarettes.
Read More »NCHR Testifies at the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting on Shield Guardant Health
May 23, 2024: NCHR provided public testimony at the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting regarding the safety and effectiveness of Shield Guardant blood test for colorectal cancer screening. We advised more research was needed prior to approving the test due to the low sensitivity in detecting colorectal cancer at the earliest stages.
Read More »