September 28, 2020: We support the review’s examination of the relative risks and outcomes of cervical ripening in the outpatient compared to the inpatient setting. However, an overarching problem in the review is that it does not examine the role of patient-centered outcomes and satisfaction.
Read More »On Medical Treatments & Products
NCHR’s Testimony to FDA Regarding Reclassification of 4 Medical Devices
September 8, 2020: NCHR’s Dr. Meg Seymour expressed concern about the lack of sufficient public
information available to evaluate the reclassification of four medical devices. Her testimony
emphasized that FDA executive summaries provide minimal details about study design, patient
demographics, and clinical endpoints, making it impossible to determine if the proposed special
controls would adequately mitigate risks.
NCHR’s Public Comments on the FDA’s Draft Guidance Regarding the Development of Anti-Infective Drug Products for the Pediatric Population
August 31, 2020: We have several recommendations regarding the FDA’s draft guidance regarding the development of anti-infective drugs for the pediatric population.
Read More »NCHR’s Testimony to FDA Regarding Proposed Labeling for TRELEGY ELLIPTA
August 31, 2020: We share the concerns of the FDA scientists that trends shown by the data do not support the claim that TRELEGY improves all-cause mortality.
Read More »NCHR’s Testimony to FDA on Belantamab Mafodotin
July 14, 2020: Based on the data discussed today, it is difficult to determine how well Belantamab Mafodotin works and whether its effect is clinically meaningful. To approve a treatment for which the benefits do not clearly outweigh the risks creates additional risk for those who are already suffering.
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