September 26, 2024: NCHR appreciates the improvements made in the 2024 FDA draft guidance for Diversity Action Plans but the draft lacks incentives to encourage companies to comply. The indication and label should reflect the evidence for sex, race, ethnicity, and ages of patients studied. Approval should only be for patients for whom clear evidence of safety and effectiveness was provided.
Read More »Author: trn
Why are Youth Suicides Increasing?
The last 20 years has seen a troubling spike in suicides in the U.S., including youth suicides. Potential causes include isolation and depression during the COVID-19 pandemic, the influence of social media, and access to firearms and lethal pills. Further research is essential to determine how to best support vulnerable groups and youth mental health in ways that prevent suicides.
Read More »FDA to launch ‘active’ monitoring system to improve medical device safety
Association of Health Care Journalists, September 18, 2024: AHCJ questions the usefulness of FDA’s new active monitoring system to improve medical device safety and NCHR and other experts do too. The FDA plans to start by monitoring two types of devices in the first year but there are thousands of devices that were never studied for safety or effectiveness so that is not going to keep patients safe anytime soon.
Read More »Testimony of Diana Zuckerman at the FDA Gastrointestinal Drugs Advisory Committee Meeting on Ocaliva
September 13, 2024: NCHR’s Dr. Diana Zuckerman tells FDA Advisory Committee that the data presented on Ocaliva for a rare liver disease does not meet the FDA’s standard of evidence to keep it on the market and that the results do not prove that OCA prevents death or prevents the need for a liver transplant.
Read More »Testimony of Diana Zuckerman at the FDA Antimicrobial Drugs Advisory Committee Meeting on Sulopenem
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.
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