Cures Act Implementation Deadlines: What to Expect in 2018

Regulatory NewsRegulatory News | 25 January 2018 |  By 

Implementing 2016’s 21st Century Cures Act provisions has been no small task for the US Food and Drug Administration (FDA). And in 2018, more than 10 statutory deadlines are coming.

The deadlines for this year are centered around two dates: 13 June and 13 December 2018, though other reports and final guidance will be released in 2019 and beyond.

Coming in June or before then will be plans for a public meeting on novel clinical trial designs, a list on combination product innovation and draft guidance on patient-focused drug development and humanitarian device exemptions.

And coming by December, FDA will have to create a real world evidence plan, which FDA has made strides on in the medical device space, and a plan for standards for regenerative medicine and regenerative advanced therapies, which back in November FDA outlined a new policy framework for.

By the end of next month, FDA will also have to submit a report to Congress on regenerative advanced therapies.

In addition, by December, FDA will have to submit reports to Congress on the limited population pathway, which is aimed at streamlining the development programs for certain antibacterials and antifungals, other compliance activities and the protection of human research subjects.

Also by December, FDA will have to put together a plan for a public meeting on the qualification of drug development tools, which the agency has said it will work to develop and refine for specific uses.

Another annual report to Congress will be on FDA’s spending of innovation funds, which the agency already began sending last year.

Last July, FDA released a plan submitted to Congress for how it will use $500 million in new funding from the law over the next nine fiscal years.

Also in 2017, FDA released draft guidance on a designation for breakthrough medical devices. That designation will supersede the Expedited Access Pathway designation, which companies have begun noting in recent months.

21st Century Cures Act Deliverables


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