CBS News, December 20, 2023: CBS News article dives into the lack of FDA oversight within the medical device industry. Increased patient harm is exposed in lawsuits and records.
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NCHR Comments on USPTO-FDA Collaboration and Engagement
February 6, 2023: NCHR’s public comments strongly support FDA’s decision to prioritize USPTO-FDA collaboration. Access to generic drugs and biosimilars is critically important and abuse of the patent system remains a major barrier. We are hopeful that meaningful collaboration between the FDA and the USPTO will result in substantial improvements.
Read More »NCHR Comments on the FDA Preliminary Assessment of Potential Non-prescription Naloxone Products
January 17, 2023: NCHR agrees with the FDA’s assessment that certain types of naloxone drug products could be safe and effective for non-prescription use but training is needed to use it correctly in urgent situations. We also support FDA’s request for more research to determine how to provide the most effective instructions and labeling for non-prescription naloxone products.
Read More »NCHR Comment on FDA Proposed Rule on the Protection of Human Subjects and Institutional Review Boards(IRB)
December 28, 2022: NCHR public comments on FDA’s proposed rule supports a single IRB for all U.S. centers in multi-center clinical trials and greater diversity among IRB members. We urge the FDA to require more explicit improvements to address known weaknesses in oral and written informed consent procedures and address demographic differences in efficacy and safety of treatments studied clinical trials.
Read More »NCHR Comments on FDA Ethical Considerations for Clinical Investigations of Medical Products Involving Children
December 27, 2022: We address suggestions of how to improve this guidance to promote safety and efficacy in clinical investigations of medical products involving children. Many new medical products that are used by children are never actually tested on them or approved for them prior to entering the market. Many children are either left with no treatment options or given products “off label” that have not been tested for safety, effectiveness, or dosage requirements in patients of their age, size, or weight.
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