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.…
The U.S. House of Representatives is expected to pass a $6.3 billion piece of legislation on Wednesday designed to spur medical innovation, speed access to new drugs, expand mental health treatment, and combat opioid abuse. The bill, known as the 21st Century Cures Act, provides $4.8 billion to the National Institutes of Health (NIH)…
U.S. lawmakers finally reached an agreement on legislation to fund cancer research and accelerate new drugs to market. But the plan to pay for the proposal remains a sticking point for some health groups. The $6.3 billion bill, known as the 21st Century Cures Act, gets more than half its funding by revoking $3.5 billion…
Biosimilars are among the newest threads in the fabric of cancer treatment in the United States, and they are spawning numerous questions for oncologists and patients with cancer. Many of these questions were taken up by participants in a recent Washington forum on “The Future of the U.S. Biosimilars Market” sponsored by the Friends of…
Note: This press release was originally distributed by the Reagan-Udall Foundation and can be viewed HERE. November 21, 2016 – The Reagan-Udall Foundation for the FDA (RUF), an independent nonprofit organization that works to advance regulatory science to help support the scientific mission of the U.S. Food and Drug Administration (FDA), has elected Ellen…
