With self-congratulatory zeal and smiles all around, huge bipartisan majorities in Congress have just passed legislation to speed the discovery of cures for killer diseases. At the same time, Republican leaders have been devising a strategy to undo the Affordable Care Act, which has done more than any law in a generation to treat people…
The U.S. Senate voted overwhelmingly on Wednesday to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines. It will also provide funding for cancer and Alzheimer’s research, help fight the opioid epidemic, expand access to mental health treatment and advance research into precision medicine. Two years…
More than 200 people celebrated the opening of the GW Cancer Center Wednesday night in the Science and Engineering Hall. The center features new labs and equipment on the eighth floor of the Science and Engineering Hall. Before the ribbon cutting ceremony, leaders in the University and the center said that this location will…
Executive Summary Enrolling patients with stable brain metastases, HIV-positive status and other traditionally excluded groups could give sponsors a marketing edge, but trials should be designed to examine drug effects on such populations separately from the more traditional study population, stakeholders said. Broadening the eligibility criteria for cancer clinical trials could enable…
This week, Congress is taking back up a sweeping bill introduced last year that would expand medical research funding while also loosening the regulations for approving new drugs and medical devices. While the legislation has undergone revisions, it still includes many of the deregulatory provisions that have drawn criticism from some consumer safety advocates. Back…
The House overwhelmingly backed broad legislation Tuesday to increase federal support for medical research, advancing a long-anticipated bill that is expected to clear the Senate soon and get President Obama’s signature. The $6.3-billion bill — known as the 21st Century Cures Act — attracted strong bipartisan support, with 218 Republicans and 174 Democrats voting…
Executive Summary FDA’s evolving efforts to develop a ‘structured risk-benefit’ framework is playing an important role in accelerating access to drugs for rare diseases and specific subgroups in cancer; there may be less attention to an accompanying phrase that is growing in currency as a factor in the equation: ‘regulatory risk’ – the term for…
The updated 21st Century Cures bill may revise some financial disclosure requirements designed to prevent federally funded scientists from cozying up to drug and device companies. The House is expected to vote Nov. 30 on a newly revised Cures bill, which lawmakers released late Nov. 25 as an amendment to the tsunami bill (H.R.…
A 996-page bill that seeks to speed up the approval of new medicines and medical devices is expected to head to the House for a vote Wednesday, amid criticism that the complicated legislation is being rushed through without sufficient scrutiny. Called 21st Century Cures, the legislation earmarks $6.3 billion for biomedical research, opioid abuse prevention and support for the agency that…
Executive Summary Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence. FDA may wind up only meeting the minimum requirements for establishing intercenter institutes within the agency that are included in the new version of the 21st Century Cures bill.…
