FDA's new Plausible Mechanism Pathway

The US FDA has published an initial "Sounding Board" piece in the New England Journal of Medicine, outlining a regulatory path to market entry for products where a randomized trial is not feasible. 

"Once a manufacturer has demonstrated success with several consecutive patients with different bespoke therapies, the FDA will move toward granting marketing authorization for the product. Manufacturers will then be able to leverage platform data from such personalized products to gain marketing approval for similar products in additional conditions. Depending on the strength of evidence, either the accelerated or the regular pathway may be utilized."

Read more here.