Formal FDA review may not be needed for interpreting results of advanced genetic screening tests if the associated databases contain reliable information, the agency’s device chief said. Jeffrey E. Shuren, director of the Center for Devices and Radiological Health, made the remarks while explaining the Food and Drug Administration’s plan to regulate next-generation sequencing…
Cancer seems to touch most Americans, with an estimated 1.6 million diagnosed in 2016, and nearly 40% of Americans diagnosed at some point during their lifetime. That’s why speeding therapies to market is at the heart of the newly organized Oncology Center of Excellence (OCE), an initiative meant to support an integrated approach to evaluating products for cancer…
A conversation with The Cancer Letter and the experts listed below. Jeff Abrams, NCI acting director for clinical research and associate director of the NCI Cancer Therapy Evaluation Program. Abrams wrote his responses with Elad Sharon. Jeff Allen, president and CEO of Friends of Cancer Research, an advocacy organization based in Washington, DC…
Executive Summary In an interview, Margolis Center for Health Policy’s Mark McClellan and Gregory Daniel talk about their recent move from Brookings to Duke, the breadth and impact of their work with FDA on drug development issues, and opportunities for potential future collaborations under PDUFA VI. Mark McClellan, the former FDA commissioner and…
Friends of Cancer Research (Friends) has announced that its Executive Director, Jeff Allen, PhD, will assume the role of President and CEO of the organization. Friends’ founder, Ellen Sigal, PhD, will continue with the organization as Board Chair. Dr. Allen will become the day-to-day lead of Friends’ scientific and policy programs and organizational operations, in…
David R. Gandara, MD, director, Thoracic Oncology Program, professor, senior advisor to director, UC Davis Comprehensive Cancer Center, treasurer, International Association for the Study of Lung Cancer (IASLC), discusses the Lung Master Protocol (Lung-MAP) Trial and how it is an example of a rational clinical design that will impact patient care. Gandara shared this insight…
The National Cancer Moonshot Initiative is not slated to receive funding in fiscal 2017—neither the House nor Senate appropriations bill includes the $680 million the White House proposed for Vice President Joe Biden’s project. Despite great bipartisan breast-beating in support of boosting the NCI and NIH budgets, Congress has not dedicated funding for the…
Clinical laboratories could face significant costs if the FDA moves forward with plans for lab-developed tests, the chairman of a Senate committee said Sept. 20. Vanderbilt University’s lab in Nashville, Tenn., for example, could spend $30 million to $75 million to get Food and Drug Administration approval for a single high-risk laboratory-developed test (LDT)…
Senate health committee Chairman Lamar Alexander (R-TN) floated creating a new regulatory agency to oversee lab-developed tests, which he told lawmakers would be preferable to the current duplicative regulation by CMS, FDA and state regulators. He also told reporters he hoped FDA would not release a final version of its controversial draft guidance bringing LDTs…
Executive Summary Blue ribbon panel has plenty of industry-friendly recommendations on ways to accelerate oncology science, but with the clock ticking down on the Obama Administration, the question is whether the recommendations have any political traction. Recommendations from Vice President Joe Biden’s Cancer “Moonshot” Blue Ribbon Panel have a specific emphasis on patient-focused research,…
