Executive Summary US FDA drug reviewers argue that enrolling more heterogeneous patient populations could result in fewer postmarketing requirements and earlier satisfaction of pediatric study obligations. The US FDA’s push to expand oncology trial eligibility criteria includes highlighting the regulatory benefits for sponsors who pursue such strategies. Broadening eligibility criteria to include cohorts…
To address the shortfall of new oncology drugs developed for pediatric cancer patients, the Friends of Cancer Research (FOCR) convened a forum with invited speakers in Washington, D.C. Speakers discussed the feasibility of master trial platforms for early phase studies of multiple molecules concurrently across a range of pediatric cancer types, as well as prioritization…
President Donald Trump’s pick to lead the Food and Drug Administration, Scott Gottlieb, is a physician, a cancer survivor, a venture capitalist and a government insider who has long said he wants to tear down the wall of FDA regulations he believes is holding back innovation. “In so heavily prioritizing one of its obligations…
Breakthrough Therapy Designation is described on the FDA website as “a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).” It was signed into law in 2012,…
Big changes could be coming to the way new drugs are approved by the Food and Drug Administration. The Trump administration and incoming new leadership at the FDA, coupled with the implementation of the 21st Century Cures Act, signed into law by President Obama in December, may shake up the status quo for the prescription…
Friends of Cancer Research launched an online learning community, ProgressForPatients.org. The site is home to two new programs Friends has been developing over the course of the last year, Friends’ Advocacy Education and Advocacy Alliance. “We set out to create an online community, a place where patients and their advocates who wish to bring…
The budgetary sky isn’t falling for medical research, at least not according to NIH director Francis S. Collins. Collins said March 27 he’s not especially worried about President Donald Trump’s proposal to cut the NIH’s $32 billion annual budget by nearly 20 percent for fiscal year 2018. He spoke at the American Association for…
A key cancer research advocate warned lawmakers Wednesday (March 22) that the Trump administration’s hiring freeze and recent proposed budget cuts to the National Institutes of Health (NIH) could have a serious impact on the future of FDA’s recently launched Oncology Center of Excellence (OCE), and urged lawmakers to swiftly pass PDUFA VI as written.…
The House Energy and Commerce Committee’s health subcommittee pushed the Prescription Drug User Fee Act (PDUFA) higher up the priority list during a hearing earlier this week. PDUFA, which supports the review and regulation of innovative drug products and helps ensure patients receive timely access to safe and effective new therapies, must be reauthorized…
To hear Bob Godshall tell it, he has no business being alive. Eleven years ago, at age 72, he was diagnosed with multiple myeloma, a type of bone cancer. His doctors told him to get his affairs in order. He’d be gone within a year. But when Godshall learned some myeloma patients bought…
