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Author: Caroline Bradford

NCHR Comments on Consumer Product Safety Commission Scientific Integrity Policy

December 4, 2023: NCHR urged CPSC to strengthen protections for scientists against retaliation and instill consequences for violations of the scientific integrity policy.

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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.

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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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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November 29, 2023: In response to FDA’s draft guidance on patient medication information guides, NCHR recommends that the FDA includes information on important drug interactions and develops a strategy to ensure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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Patient, Consumer, and Public Health Coalition Letter to FDA Regarding Consumer Representatives in Advisory Committees

November 20, 2023: The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals are erroneously categorized as Consumer Representatives on FDA Advisory Committees.

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