December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition told FDA that if a predicate device for 510(k) review does not align with the best practices identified in the FDA guidance, the device should be submitted to De novo or PMA instead.
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Patient, Consumer, and Public Health Coalition Comments on the FDA Proposed Rule Regarding Laboratory Developed Tests
December 4, 2023: The PCPH Coalition supported the FDA proposed rule on lab-developed tests (LDTs) to diagnose diseases and genetic issues, with the exception of FDA’s proposed increased use of third-party reviewers.
Read More »NCHR Comments on FDA Proposed Guidance “Stimulant Use Disorders: Developing Drugs for Treatment”
December 4, 2023: NCHR expressed concerns that accelerated approval for stimulant addiction treatment will jeopardize patient safety and drug effectiveness. We also recommended the study design include a diverse patient population to best reflect the intended patient population, and improving study end-points to be more reflective of real-world practice.
Read More »NCHR Comments on FDA’s Proposed Rule “Medication Guides: Patient Medication Information”
November 29th, 2023, in response to FDA’s draft guidance on patient medication information guides, NCHR recommends that the FDA includes information on important drug interactions and develops a strategy to ensure the materials meet the average health literacy of the population.
Read More »Testimony of Diana Zuckerman at FDA Advisory Panel on Blood Irradiators
November 7, 2023: Blood irradiator devices have been used for decades on cancer patients to try to prevent metastasis. NCHR agrees with FDA there is no evidence that they benefit patients and it is clear the radiation can be harmful. At an FDA Advisory Committee meeting in November 2023, we urged FDA to finally require scientific studies if companies want to continue to sell these devices.
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