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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Featured Presentation by Diana Zuckerman at the CDC Childhood Lead Poisoning Prevention Program Annual Meeting
December 5, 2023: Dr. Diana Zuckerman was the featured speaker at the CDC’s annual childhood lead prevention (CLPPP) meeting in Atlanta, explaining the risks of lead in artificial turf, playground surfaces, recycled rubber tiles, and rubber mulch for plants. Here is her presentation with the photos from her slides.
Read More »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November 29, 2023: In response to FDA’s draft guidance on patient medication information guides, NCHR recommends that the FDA includes information on important drug interactions and develops a strategy to ensure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.
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