The Food and Drug Administration on Monday announced a proposal that would kickstart the development of customized treatments for patients with hard-to-treat diseases, according to the Associated Press.
That includes treatments for rare genetic conditions that the pharmaceutical industry has long considered unprofitable.
If implemented, the guidelines would establish a new pathway for bespoke therapies that have only been tested in a small number of patients due to the challenges of conducting larger studies.
The shift has long been sought by patients, advocates and researchers focused on rare diseases, which often do not fit within the pharmaceutical industry’s business model or the FDA’s traditional drug-approval system.
