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.
On Medical Treatments & Products
NCHR’s Public Comments on the FDA’s Draft Guidance Regarding the Development of Anti-Infective Drug Products for the Pediatric Population
August 31, 2020: We have several recommendations regarding the FDA’s draft guidance regarding the development of anti-infective drugs for the pediatric population.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.
Read More »NCHR Comments on Laparoscopic Power Morcellators
April 27, 2020. We are disappointed that the FDA’s plan to update the 2014 recommendations for the labeling of laparoscopic power morcellators (LPMs) does not adequately strengthen the warnings.
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