Senate Passes Bill Removing Animal Testing Requirements For Drugs

The Senate on Thursday (Sept. 29) passed by unanimous consent a bipartisan bill that would eliminate requirements that experimental drugs first be tested on animals. The legislation, sponsored by Sens. Cory Booker (D-NJ) and Rand Paul (R-KY), gives drug sponsors the option to use rigorous, proven non-animal testing methods when appropriate. The bill maintains sponsors’ abilities to use animal testing where it is appropriate. Alternative methods to animal testing could include cell-based assays, organ chips and micro-physiological systems, sophisticated computer...
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FDA, VA Team Up To Spur Medical Device Innovation, Telemedicine

FDA and the Veterans Health Administration on Wednesday (Sept. 28) announced they will collaborate to develop and disseminate new tools to test the safety and effectiveness of medical devices and emerging technologies, with an initial focus on interoperable systems that can help advance automation, telemedicine and personalized health care. The collaboration, established through a memorandum of understanding, is expected to spur development of “off-the-shelf” testing tools that can provide innovators with straightforward, reproducible and cost-effective testing methods throughout the product...
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FDA, VA Team Up To Spur Medical Device Innovation, Telemedicine

FDA and the Veterans Health Administration on Wednesday (Sept. 28) announced they will collaborate to develop and disseminate new tools to test the safety and effectiveness of medical devices and emerging technologies, with an initial focus on interoperable systems that can help advance automation, telemedicine and personalized health care. The collaboration, established through a memorandum of understanding, is expected to spur development of “off-the-shelf” testing tools that can provide innovators with straightforward, reproducible and cost-effective testing methods throughout the product...
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Latest FDA Alert Highlights Medical Device Cybersecurity Concerns

FDA’s warning that certain insulin pumps are vulnerable to cyberattacks, potentially allowing hackers to prevent insulin delivery or change patients’ dosages, marks the first FDA cybersecurity alert for a medical device since a new guidance on the topic was issued in April, and comes as the FBI identifies medical devices vulnerabilities as a growing concern. The alert was issued Sept. 20 for the Medtronic MiniMed 600 Series insulin pump system , which includes several different devices with components that communicate...
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