The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

Vera Pomerantseva (VP): Protocol deviation management is not a new process in the industry - it's rather complex. There is a lot of variability in how protocol deviations are managed by sponsors.