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Regulatory News | 05 May 2017 | By Zachary Brennan
Thanks to the 21st Century Cures Act, the US Food and Drug Administration (FDA) over the next eight years will have access to more than $500 million in new funds for a variety of new drug, device and clinical trial work.
According to a proposal of how these new funds would be used, subject to the congressional appropriations process, FDA said on Friday the bulk would be dedicated to sections of the law on “Advancing New Drug Therapies” and “Patient Access to Therapies and Information.”
Other funds will go to subsections of the law on modernizing clinical trial designs, patient-focused drug development, medical device innovation and improving scientific expertise and outreach at FDA.
One of the more controversial aspects of the law, which would allow FDA to “rely on qualified data summaries to support approval of a supplemental application for a qualified use of a drug” is further explained by the proposal as the initial focus of these data summaries “will be on supplemental applications for cancer drugs,” though the agency qualifies this by noting that “summaries may be used if the drug has existing safety data that is available and acceptable to FDA as part of the supplemental application and if the full data used to develop the qualified data summaries are submitted in the application.”
The idea behind the use of such data summaries is to save time and reviewer resources, as reviewers may not need to reexamine the primary raw datasets or conduct additional analyses of the data.
FDA staff in the newly formed Oncology Center of Excellence will develop policies and procedures for implementation of summary-level review for appropriate oncology applications, the proposal says.
Another aspect of the law that could shift the needle for industry is a provision to establish a qualification process for drug development tools (DDTs), including biomarkers and clinical outcome assessments.
“Once a DDT is qualified under this new process, any sponsor may use it for its qualified context of use to support an application for approval or licensure of a drug or to support the investigational use of a drug,” FDA notes.
FDA’s Center for Biologics Evaluation and Research (CBER) will also use innovation funds to facilitate a public process with the National Institute of Standards and Technology and other stakeholders to coordinate and prioritize the development of standards and consensus definitions of terms for new regenerative products. Meanwhile, use of FDA’s new Regenerative Medicine Advanced Therapy (RMAT) designation created under Cures has already begun.
Other funds will go to raising the eligibility cap for a humanitarian medical device exemption from 4,000 to not more than 8,000 individuals in the US, exempting specific categories of medical software from FDA regulation, dealing with an expected influx of new breakthrough devices, combination product work, developing a framework and draft guidance on the use of real world evidence and novel trial designs, grants for studying continuous manufacturing and the reauthorization of the pediatric priority review voucher program.
Proposed FDA Work Plan for 21st Century Cures Act Innovation Account Activities
Tags: 21st Century Cures, FDA innovation, FDA innovation funds, DDTs