NCHR supports the CPSC’s new proposed guidelines for infant rockers that will help to strengthen safety standards for such products. We offered suggestions to the rule, including adding a minimum age of use of at least 4 months old, more strongly discouraging the use of rockers for sleeping, and making physical changes that minimize the use for sleeping and the risk of injury. We also urged the CPSC to strengthen warning/labeling requirements, prevent stockpiling of rockers that don’t meet the new requirements, and support future research into the safety of rockers and related products.
Read More »Author: Caroline Bradford
Deep flaws in FDA oversight of medical devices — and patient harm — exposed in lawsuits and records
CBS News, December 20, 2023: CBS News article dives into the lack of FDA oversight within the medical device industry. Increased patient harm is exposed in lawsuits and records.
Read More »NCHR Comments On FDA’s Draft Guidance Regarding the Confirmatory Evidence Needed to Demonstrate A Drug’s Effectiveness
December 18, 2023: NCHR urged the FDA to institute stronger scientific standards to confirm that a new drug is effective, preferably two randomized, double-blind, clinical control trials. Patients deserve drugs that are proven to work, not drugs that possibly work.
Read More »NCHR Comments On the FDA’s Draft Guidance Regarding the Development of Novel Drugs for Diabetic Foot Infections
December 18, 2023: NCHR urges the FDA to oppose using non-inferiority trials as evidence for new antibiotic treatments for diabetic foot infections. FDA defines “non-inferior” to include “slightly worse” but new antibiotic treatments should be better than standard treatments. Otherwise they don’t benefit patients and worsen antimicrobial resistance.
Read More »Patient, Consumer, and Public Health Coalition Letter to Senator Braun Regarding the Promising Pathways Act
NCHR and the Patient, Consumer, and Public Health Coalition oppose the Promising Pathways Act, which would allow FDA to approve drugs that aren’t proven to work and then to remain on market for up to 8 years without proof of effectiveness. The bill is supposed to help provide treatment for the most serious diseases, but is poorly written, providing false hope, huge financial burdens for patients and Medicare, and undermining existing FDA pathways that are more targeted to urgently needed treatments.
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