Waking Up to REMS (Part 2): What You Don't Know Can Hurt You
This article was originally published in RPM Report
Executive Summary
The last thing anyone in the biopharma sector needs is a less predictable drug review process, but there is no denying that the new drug safety law has added another level of uncertainty to the regulatory affairs process. The only thing worse is the fear that some in industry know more than others about the new rules of the road.