CFSAN regulatory affairs chief Douglas Stearn says a regulatory pathway wouldn’t be an open door for CBD-containing food and supplements due to concerns about the ingredients’ safety. Legislation from Congress might "do something with CBD that’s different than the rest of the Food, Drug and Cosmetic Act," he says. 

A Phase II trial of the CH24H inhibitor showed a statistically significant benefit in children with the rare epilepsy syndrome Dravet Syndrome, but not in Lennox-Gastaut syndrome (LGS).

Applications to widen the therapeutic indications of up to 20 approved drugs will be decided on this week at the European Medicines Agency.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.