April 12, 2016. NCHR realizes that there is currently an unmet need for a drug to treat patients whose NSCLC has become resistant to first line TKI therapies via the T790M mutation. However, this does not warrant the approval of yet another drug that will not significantly improve outcomes for these patients. Fortunately, there is hope on the horizon, because the preliminary results for osimertinib for the same patients appears to be much more effective with fewer serious side effects.
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NCHR Testimony at FDA on Pimavanserin (Nuplazid) for Parkinson’s Patients with Psychosis
March 29, 2016. Because of concerns over the limited efficacy, the test used, and the high incidence of adverse events, NCHR urges FDA to not support the approval of pimavanserin [Nuplazid].
Read More »NCHR Comments on the Proposed Order Reclassification of Electroconvulsive Therapy Devices
March 28, 2016. Our review of the research indicates that ECT devices should remain as class III and should be subject to PMA review. The risks for patients associated with down classification of ECT devices for depression greatly outweigh any presumed benefit.
Read More »NCHR Testimony at 2016 FDA Workshop on Point of Care Devices for Monitoring Warfarin Therapy
March 18, 2016. Point of care PT/INR devices represent an increasingly important part of the healthcare landscape. Transparent and robust design, performance studies, and clear data supporting safety and effectiveness are required to avoid device problems that could have wide-reaching consequences for patients and public health. The only way to gather such data is through a rigorous PMA process.
Read More »NCHR Testimony at 2016 FDA Science Board Meeting on Opioids
March 1, 2016. Opioid abuse is a crisis in the US. We urge the FDA to perform its own independent assessment of the effectiveness of REMS and make this data publicly available. More transparency is needed to enable us all to work together to find more effective solutions to the challenge of opioid abuse.
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