New FDA Guidance Aims to Speed Early Drug Development
Last week, the Food and Drug Administration (FDA) released two new guidance documents and a final rule intended to streamline the early clinical development of new drugs and biologics for cancer and other diseases. The documents represent strategic actions that are part of the agency's Critical Path Initiative. The Critical Path is a blueprint for updating the technologies and tools needed to optimize the process of discovery, development, and delivery of medical products. These specific guidances address major barriers in the early development of new interventions, including testing small quantities of new agents prior to undertaking full-scale clinical trials and evaluating new investigational agents in humans before demonstrating their manufacturability.
The joint NCI-FDA Interagency Oncology Task Force (IOTF), which was established in 2003 to enhance and accelerate the overall process of developing new cancer interventions, has focused extensively on these issues as part of its work to improve the overall cancer drug development process. Read more
NCI Advisors Explore Future Research Investment Strategies
Last week, NCI leadership held an important retreat with members of the institute's primary advisory panels. This was the 3rd annual NCI Joint Boards Retreat, and together we grappled with how NCI programs can continue their pioneering innovative trajectory, given the current fiscal limitations facing biomedical research.
As the discussion at the retreat illustrated, the ongoing budget constraints will require difficult but creative choices. The retreat also reinforced for me, however, the resolve of staff and the community to take the necessary steps to ensure continued progress against cancer by accelerating the pace of discovery, development, and delivery.
The President recently signed the appropriations bill that provides funding for the Department of Health and Human Services (HHS) for fiscal year 2006. The bill includes $4.842 billion for NCI. However, after a government-wide 1 percent reduction, as well as adjustments made for recisions, assessments, and mandatory increases, NCI starts FY 2006 with fewer dollars than FY 2005, an amount that was already lower than the previous year. Read more