FDA’s Science Board Reviews Agency’s $500 Million Cures Act Work Plan
The FDA’s Science Board reviewed and largely supported the agency’s proposed plan for implementing the 21st Century Cures Act over the next nine years.
The work plan for spending the $500 million slated to implement the Cures Act, focuses mainly on patient-focused drug development, the qualification of drug development tools and advancing regenerative medicine research and development.
The agency proposes allocating a total of $185.2 million, including $23.9 million for fiscal 2018, for supporting reviews of combination products and accelerated approvals of regenerative therapies, as well as the use of data summaries for expanding indications.
The FDA will further refine its qualification process for biomarkers and other drug development tools to bring it in line with the Cures Act, ShaAvhrée Buckman-Garner, director of CDER’s Office of Translational Sciences, told the committee.