The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA) on finding the optimal dosage for cancer drugs could slow drug development. On the other hand, several stakeholders praised the guidance while asking for additional details such as how to factor…
Industry should return to large, simple clinical trial designs that rely on randomization and endpoints that matter most to patients – and remove the excessive data collection that often leads to problems with recruitment, retention and trial cost, Food and Drug Administration Commissioner Robert Califf said. “Randomization as a tool is an amazingly elegant tool”…
US Food & Drug Administration Commissioner Robert Califf is touting the modernization of food safety inspections as an important initiative of his second stint at the helm of the agency – and is underscoring that the “new vision” for foods will have ripple effects for drugs and biologics. The modernization work that FDA is undertaking…
City of Hope physician executive Edward S. Kim joined Friends of Cancer Research’s board of directors. Kim is physician-in-chief and senior vice president City of Hope Orange County, Construction Industries Alliance City of Hope Orange County physician-in-chief chair, and vice physician-in-chief and professor at City of Hope National Medical Center. A clinician, researcher, and…
AND THEN THERE WERE THREE — The third major insulin manufacturer, Sanofi, said Thursday it will cut the list price of its most widely used insulin by 78 percent starting in January 2024. If President Joe Biden decides to run for re-election in 2024, he is expected to use insulin price cuts as an example of…
Friends of Cancer Research appointed Edward S. Kim, MD, MBA, FACP, FASCO, to its board of directors. Kim — an associate medical editor for Healio | HemOnc Today — is physician-in-chief and senior vice president of City of Hope Orange County. He also is vice physician-in-chief and professor with City of Hope National Medical Center. Friends of…
The top job at the National Institutes of Health, a prestigious role that has attracted a Nobel Prize winner and other leading scientists, is going unfilled as candidates back out. At least two potential choices for the job have walked away, and the White House has struggled finding qualified candidates willing to fill a job…
The Center for Biologics Evaluation and Research is receptive to the idea of creating a regulatory framework on data extrapolation techniques to support the development of next-generation oncologics, CBER Senior Science Advisor Ingrid Markovic said during a Friends of Cancer Research webinar on 8 March. Markovic, who is a CMC policy lead in the CBER Office of…
NEW YORK – Drugmakers working with the US Food and Drug Administration to bring more effective, efficient, and less toxic cancer cell therapies to market are finding that while the agency has gotten better at communicating with industry, a lack of regularity clarity on manufacturing processes and product characterization is still thwarting their development programs.…
Regulatory Background What is the Office of Information and Regulatory Affairs (OIRA)? OIRA sits within the White House Office of Management and Budget (OMB), where it serves as the “central authority for the review of Executive Branch regulations, approval of Government information collections, establishment of Government statistical practices, and coordination of federal privacy policy.” To ensure consistency in…
