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…
Lawmakers are committed to reauthorizing drug user fee agreements well before the present ones expire at the end of September, a House of Representatives committee hearing was told Wednesday. But the process is complicated by the advent of a new administration and its policy and budget statements, while Congress discusses agreements that were hammered…
Executive Summary White House allowed agency to hire some new employees, but lawmakers remain concerned about federal hiring freeze’s effect on FDA. The US FDA apparently is reaping the benefits of an exemption to President Trump’s federal hiring freeze. And while the number of new hires has yet to be revealed, it appears several new…
The focus of a recent hearing of Senate Health, Education, Labor and Pensions (HELP) was the FDA’s user fee agreements, or monies the agency receives from drug and medical device manufacturers to accelerate the review process. But prior to the hearing, every Democratic member of the HELP committee signed a letter to Chair Lamar Alexander…
House lawmakers, FDA officials and industry stakeholders all praised the success of the agency’s breakthrough designation in lowering drug development times, and stressed that the pending Prescription Drug User Fee Agreement (PDUFA) will bring important resources to the breakthrough effort. The widespread commitment to the designation at a House hearing Wednesday (March 22) is likely…
