When surrogate endpoints are used for accelerated approvals in advance of more compelling functional outcomes, how long should the duration of the confirmatory studies be?

Saunders will oversee the consumer health, pharma and medtech eye health and vision care specialist, returning to where he got his start as a chief executive before earning a reputation as one of industry’s biggest dealmakers.

Saunders will oversee the eye specialist, returning to the firm where he got his start as a chief executive before earning a reputation as one of industry’s biggest dealmakers.

Research targeting botanicals generally, as well as cannabis, as potential APIs is increasing, a factor in CDER’s publication of cannabis trials guidance, the FDA’s Norman Birenbaum says in an interview.