September 22, 2022: Two bills led by Sen. Smith take critical steps to help protect access to safe and effective reproductive health care products. We at NCHR are appreciative of her work to act in the face of the many challenges presented following the Dobbs decision.
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NCHR’s Testimony on the FDA’s Proposed Reclassification of Computer-Aided Devices which Provide Adjunctive Diagnostic Information about Lesions Suspicious for Melanoma from Class III Devices to Class II Devices
July 29, 2022. We do not support the proposed reclassification of the two skin lesion analyzers, MelaFind and Nevisense, from Class III to Class II. We have 2 major concerns: There is no guarantee that newly developed devices cleared through the 510(k) process would be as accurate as those currently on the market. For that reason, newly developed devices should be reviewed through the PMA process and there is a clear risk of false positive and false negative results, misuse, and device failure, and the FDA has not provided adequate evidence that these risks can be adequately mitigated with the Class II special and general controls listed in the executive summary. As described, FDA cannot ensure that there will be reasonable assurance of safety or effectiveness over the lifespan of the newly submitted devices.
Read More »NCHR Comments on Fostering Medical Device Improvement
July 5, 2022: This proposed draft guidance on Fostering Medical Device Improvement aligns closely with the needs of medical device companies, but not with the needs of patients and consumers. NCHR has many concerns about the proposed program.
Read More »NCHR’s Public Comment on Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting
June 21, 2022: While we agree that these potential modifications are a great step forward in ensuring that unused medications are properly disposed of, overprescribing continues to be a major problem in the U.S. There should be continued efforts to educate physicians and pharmacists on reducing the number of opioids prescribed and providing alternatives to opioid analgesic prescriptions…
Read More »NCHR Comments on Recommended Diversity Plan to Improve Enrollment of Racial and Ethnic Minorities in Clinical Trials
June 13, 2022. We strongly support FDA’s proposed recommendations which provide specific, actionable guidance for sponsors to develop a meaningful Race and Ethnicity Diversity Plan. For too long, clinically meaningful disparities in the efficacy of drugs or therapies in minority populations have been hidden by a lack of data. However, this draft proposal should go further by providing meaningful incentives for sponsors to follow the recommendations.
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