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# Cures Act MCM Provisions Outlined
- URL: https://www.fdaweb.com/cures-act-mcm-provisions-outlined/
- Published: 2017-07-19T12:00:00.000Z
- Updated: 2026-09-14T22:35:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139166

The 21st Century Cures Act contains provisions intended to facilitate development of medical countermeasure (MCM) products. In a Web site [post](https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm566498.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), FDA outlines the provisions and their effect on product development.

Examples of the provisions cited are: encouraging complex adaptive and other novel trial designs, fostering potential use of real-world evidence, establishing a Limited Populations Antibacterial and Antifungal Drug program, encouraging medical device innovations, and harmonizing FDA human subjects protections, including waivers of informed consent for minimal risk studies, with the Federal Policy for the Protection of Human Subjects.

The post also contains information about MCM-specific Cures provisions and the Emergency Use Authorization procedures. And information is presented on the MCM priority review voucher (PRV) program. FDA says it will award a priority review voucher if certain conditions are met. To be considered for a material threat MCM PRV, an MCM application must be **(1)** intended for use to prevent or treat harm from a biological, chemical, radiological, or nuclear agent (or harm caused by an MCM used against such agent) determined by the Department of Homeland Security to be a material threat; **(2)** eligible for priority review; **(3)** approved after 12/13/16; and **(4)** for a drug for which an active ingredient has not been previously approved by FDA.

According to the post, although the material threat MCM PRV program is separate and distinct from the agency’s other PRV programs, FDA intends to implement the law consistently with implementation of the other PRV programs. It also notes that some of the diseases listed under FDA’s tropical disease PRV program also are identified as material threats.