# 21st Century Cures Act

Source: https://onco.cc/terms/21st-century-cures-act/  
OnCo record `21st-century-cures-act` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A 2016 US law that funded the Cancer Moonshot, created the RMAT designation for cell and gene therapies, told the FDA to work out how real-world data could support approvals, and made companies publish how patients can request unapproved drugs.

## Summary

United States, federal statute. The 21st Century Cures Act was signed on 13 December 2016 (Public Law 114-255). Primary text: the Congress.gov record of H.R.34.

What it changed: it authorised 1.8 billion dollars over seven years for the Cancer Moonshot through the National Cancer Institute; created the regenerative medicine advanced therapy (RMAT) designation, which brought breakthrough-style benefits to CAR-T and other cell and gene therapies; required the FDA to publish a framework for using real-world evidence to support new indications and post-approval requirements (published December 2018); allowed sponsors to submit summary-level data for supplemental indications; and required manufacturers of investigational drugs for serious conditions to post their expanded access policies publicly. It also funded the NIH, reformed mental health programmes and, in its health IT title, banned information blocking and mandated patient access to electronic records through application interfaces.

The arguments: supporters call it the biggest biomedical research law in a decade; critics, including several former FDA officials, argued that pushing real-world and summary data toward approvals risked lowering the evidence bar, and that the funding was appropriated only in part. Its information-blocking rules are why patients in the United States can now pull their own oncology records into apps.

## Fields

- Kind: Term
- Last checked: 2026-09-17
- Also known as: Cures Act; 21st Century Cures; Cancer Moonshot funding; real-world evidence framework
- Tags: law; us

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/21st_Century_Cures_Act
- Wikipedia: https://en.wikipedia.org/wiki/21st_Century_Cures_Act
- Congress.gov: H.R.34, 21st Century Cures Act (Public Law 114-255): https://www.congress.gov/bill/114th-congress/house-bill/34
- FDA: real-world evidence: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [Expanded access (compassionate use)](https://onco.cc/terms/expanded-access/), [Fast Track and RMAT designations](https://onco.cc/terms/fast-track-rmat/), [FDASIA 2012 and the origins of the expedited programmes](https://onco.cc/terms/fdasia-2012/), [HIPAA (Health Insurance Portability and Accountability Act)](https://onco.cc/terms/hipaa/), [Real-world evidence](https://onco.cc/terms/real-world-evidence/), [Right to Try Act 2018 and state right-to-try laws](https://onco.cc/terms/right-to-try/)
- technologies: [Oncology EHR and real-world data platforms](https://onco.cc/technologies/oncology-real-world-data/)
- institutions: [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/)
- bottlenecks: [Data silos](https://onco.cc/bottlenecks/b-data-silos/), [Funding follows fashion, not burden](https://onco.cc/bottlenecks/b-funding-allocation/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)

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