FDA Details Cures Act Implementation

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-11-2017 17:40


The US Food and Drug Administration (FDA) has provided details of the implementation of the 21st Century Cures Act, which was signed into law on December 2016, and is designed to help accelerate medical product development and drug innovation. 

In a blog post by FDA Commissioner Scott Gottlieb, the FDA highlighted the recent transmission to Congress of a work plan and proposed funding allocation as required by the law. The law establishes an “FDA Innovation Account” for fiscal years 2017 to 2025 and authorizes $500 million in funding, subject to annual appropriations, to be used by the FDA to carry out certain provisions of the law. Consistent with the law’s requirements, the FDA developed a draft work plan demonstrating how the FDA would use that funding, subject to annual appropriations. The FDA submitted the draft work plan to FDA’s Science Board for its consideration at a public meeting in May 2017 and posted the final work plan that it delivered to Congress on June 9, 2017. It includes the recommendations from FDA’s Science Board.

In his blog post, the FDA Commissioner highlighted several key projects under the plain. The plan includes the implementation by the Center for Biologics Evaluation and Research of Regenerative Medicine Advanced Therapy or RMAT designation. This new process provides another pathway to access FDA’s existing expedited programs and is available for certain cell therapies, therapeutic tissue engineering products, and certain combination products.

Another project is the newly established Oncology Center of Excellence, which is the first inter-center institute at the FDA that focuses on a specific disease area rather than type of product. It’s designed to take advantage of the synergies that can be achieved by coordinating the clinical review of products across the FDA’s drug, device, and biologic centers to make the development of oncology and hematology medical products more efficient.

Also, in another project, the FDA’s Center for Drug Evaluation and Research with the Center for Biologics Evaluation and Research issued a plan for the development and issuance of patient-focused drug development guidances. The workshops and the new guidance will set forth the agency’s plan to facilitate a more systematic approach to gathering and using patient perspectives to inform FDA’s regulatory decision-making.

Source: FDA


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