Executive Summary Basket trials are building a path for tissue-agnostic drug development in oncology, and plans are proceeding for more master protocols in pediatric cancers, acute myeloid leukemia and pancreatic cancer. Master protocol trial designs are slowly gaining ground, especially in oncology development, as results have emerged from the early generation of basket and…
Executive Summary Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation in clinical trial design with a review of master protocols in the New England Journal of Medicine. FDA trumpeted its support for novel clinical trial designs using master protocols with a review article in the New England Journal of…
HHS will be able to transfer funds to FDA’s Oncology Center of Excellence thanks to language included in the House Appropriations Committee’s fiscal 2018 agriculture appropriations bill released Tuesday (June 27). Inside Health Policy had previously reported that FDA was using its existing funding to support OCE, and that the agency and the National Institutes…
Amid proposed federal government budget cuts, more than 250 cancer researchers, medical professionals, policymakers, patients, caregivers, survivors, and advocates will convene in Washington, D.C. today for Cancer Moonshot: One Year Later. The Summit is jointly hosted by seven of the leading cancer organizations: Cancer Support Community (CSC), American Cancer Society Cancer Action Network (ACS CAN), CancerCare,…
User fees paid by the drug and medical device industries support the salaries of hundreds of FDA staff. Federal employee union contracts require FDA to give employees 60 days’ notice if the government won’t have enough money to pay them. If a user fee bill isn’t ready to go by August 1, FDA must send…
President Donald Trump announced his intention to name Norman “Ned” Sharpless to serve as the next NCI director. The appointment was announced late on June 9. Sharpless, director of the UNC Lineberger Comprehensive Cancer Center and the Wellcome Distinguished Professor in Cancer Research, will replace Douglas Lowy, who has served as acting director at…
Some of the most innovative thinking on display at this year’s American Society of Clinical Oncology meeting came not from cancer companies, but from FDA and groups of oncologists and patient advocates who are busy rethinking how cancer drugs should be developed. The meeting was chock-a-block with data readouts showing impressive response rates to…
FDA’s Oncology Center of Excellence (OCE) is currently not receiving funding from 21st Century Cures even though both a lawmaker and the agency head said they believed resources provided through the act were intended to go to the center. An FDA spokesperson told Inside Health Policy that FDA “is currently using existing agency funds to…
The fiscal 2018 U.S. budget issued by the Trump administration calls for steep cuts in health care and scientific research while heavily boosting defense spending and offering substantial tax cuts. Dubbed “A New Foundation for American Greatness,” the spending plan was touted as a “taxpayer first” budget by Mick Mulvaney, director of the Office of…
