November 14, 2023: Medical Devices with indications associated with weight loss that are affected by this FDA draft guidance have many implications for the health and quality of life of many individuals. For this reason, it is vital for FDA guidance to be based on large sample sizes, stringent controls, and extensive follow-up to ensure the safety and efficacy of such medical devices.
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Patient, Consumer, and Public Health Coalition Comments to FDA on their Guidance for Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
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.
Read More »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.
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