A Supreme Court case involving a nursing home resident who filed a federal civil rights claim has attracted opposing views from a variety of stakeholders -- including House and Senate Democratic leadership, nursing homes, and beneficiary and children’s health advocates -- for its far-reaching scope that could affect Americans’ ability to ask courts to protect their rights under a broad range of federal programs including Medicaid and the Children’s Health Insurance Program. The Supreme Court is scheduled to hear oral...
Eisai and Biogen released positive results from a phase III clinical trial of the Alzheimer’s drug lecanemab, which analysts believe is sufficient for an FDA approval that would avoid the most severe restrictions that curbed spending on the Alzheimer’s drug Aduhelm, which the two companies also developed. Aduhelm received an accelerated approval based on surrogate endpoints, and Medicare placed harsh restrictions on the drug’s coverage; Medicare only pays for the drug when taken by patients in post-market clinical trials. Those...
The Biotechnology Industry Organization is using the president’s recent executive order on domestic biomanufacturing as ammunition against a waiver of patent protections for COVID-19 treatments and diagnostics abroad. The World Trade Organization in June partially waived patent protections for COVID-19 vaccines , and WTO members are considering expanding that waiver to coronavirus treatments and diagnostics. The Biden administration backed the initial waiver to the Trade-Related Aspects of Intellectual Property Rights, but it has kept quiet about expanding the TRIPS waiver...
In a new guidance on medical software functions, FDA said it will focus its enforcement efforts on a relatively narrow category of software that meets the definition of a medical device and could potentially harm patients if functioning incorrectly. The agency “intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended,” it wrote in the...
A new FDA document appears to significantly expand the agency’s oversight of software that helps clinicians make decisions about patients’ treatment -- a departure from a 2019 draft guidance that an industry legal expert on medical software described as alarming and said might require congressional intervention. In the guidance, published Tuesday (Sept. 27), FDA says it will consider software that gives providers specific recommendations about the treatment of patients to be a medical device, as well as software that includes...
In a new guidance on medical software functions, FDA said it will focus its enforcement efforts on a relatively narrow category of software that meets the definition of a medical device and could potentially harm patients if functioning incorrectly. The agency “intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended,” it wrote in the...
A new FDA document appears to significantly expand the agency’s oversight of software that helps clinicians make decisions about patients’ treatment -- a departure from a 2019 draft guidance that an industry legal expert on medical software described as alarming and said might require congressional intervention. In the guidance, published Tuesday (Sept. 27), FDA says it will consider software that gives providers specific recommendations about the treatment of patients to be a medical device, as well as software that includes...
