President Signs 21st Century Cures Act Into Law, FDA Commissioner Comments

The Washington Post recently reported that “The bill provides for $4.8 billion in new funding for the National Institutes of Health; of that, $1.8 billion is reserved for the “cancer moonshot” launched by Vice President Biden to accelerate research in that field. Another $1.6 billion is earmarked for brain diseases including Alzheimer’s. Also included are $500 million in new funding for the Food and Drug Administration and $1 billion in grants to help states deal with opioid abuse.” Click here for the full story.

FDA Commissioner Robert M. Califf, M.D. also shared his comments on “Cures”. Califf states in part that “Cures will also support our efforts to modernize and improve efficiency in clinical trial design. This has been an important FDA priority for decades, but exciting new approaches are now available, and we need to develop a common understanding of which designs should be used for which clinical issues. In cancer, for example, we’re already weighing the use of common control trials, which share a control arm, involve multiple different drugs for the same indication, and may even involve different companies. One of the benefits of using a common control arm is that the overall number of patients who need to be recruited and enrolled decreases, thereby optimizing clinical trial resources and potentially shortening the time it takes to get a new study off the ground.” Click here for the Commissioner’s comments or click here if you need help with and IND, clinical trial design or CRO sourcing.

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