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1 bill on this topic
“People or businesses that break certain FDA safety and quality rules for section 361 human cell and tissue products should face federal fines, including larger penalties when problems continue after written notice.”
1 bill on this topic
“For four years, FDA should publish public data on registered human cell and tissue establishments, FDA inspections of those establishments, Tissue Reference Group questions, and how long the group usually takes to respond.”
1 bill on this topic
“HHS should ask for public comments on how to update regulation of human cell and tissue products, including how FDA should assess technical factors that can affect how strictly a product is regulated.”
1 bill on this topic
“FDA should post public information explaining the Tissue Reference Group and how to ask it for advice, and should hold workshops or other learning sessions for patients, researchers, tissue establishments, universities, and industry about how human cell and tissue products are regulated.”
1 bill on this topic
“FDA should publish yearly counts, for a limited period, showing how many human cell and tissue establishments registered with FDA since January 1, 2019.”
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