The 21st Century Cures Act was designed to help accelerate drug development and approval processes and bring novel medical advances to patients quicker and more efficiently. The legislation, which was passed into law at the end of 2016, is made up of a number of important provisions, which many industry groups, researchers, healthcare providers, and patient organizations are excited to see implemented.
Last year, the FDA started the implementation process by submitting a plan to Congress detailing how it will use the allocated funds, $500 million, to enact the law over a nine-year period. The agency also released draft guidance on a designation for breakthrough medical devices as well guidance on using Real World Evidence for medical device regulatory decisions.
This year, the FDA will be expected to make further advances, with more than 10 statutory deadlines scheduled for before the end of December.
Between now and June, the FDA must release the following:
- Draft guidance on patient-focused drug development
- Plans for a public meeting focused on novel clinical trial designs
- A list on combination product innovation
In addition, by December of this year, the FDA must also release the following:
- A Real World Evidence plan for medical products
- Information on the standards for regenerative medicine and regenerative advanced therapies
- A report for Congress on the limited population pathway, an initiative aimed at streamlining the development of certain antibacterials and antifungals
- A report for Congress on the protection of human research subjects in the US
- A plan for a public meeting focused on the qualification of drug development tools
For those who want to learn more about the specific provisions within the act, as well as the scheduled deadlines for implementation, click here to access the FDA’s 21st Century Cures Act Deliverables document.