Activists have worked for years to raise awareness and funds for ALS research, as there are few treatments for the disease and they tend to be very expensive. Protests from ALS activists sparked the Right-to-Try Act, which was signed into law in May 2018.
The new guidelines include recommendations on how drugmakers should design clinical trials, measure effectiveness of treatments and interact with the FDA during the development process.
The guidelines also discuss ways to minimize unnecessary use of placebos and ideas to expedite trials.
“ALS patients deserve effective treatments, just as patients with any other disease or condition do,” wrote Acting Commissioner Ned Sharpless, MD, in the FDA’s news release.
The FDA also asked companies developing ALS treatments to provide the agency with information on the status of their research and when products may be available under expanded access or right-to-try laws.
Read the full news release here.
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