BioCentury
ARTICLE | Politics, Policy & Law

Legislation creating provisional approval pathway introduced in U.S. Senate

June 4, 2020 9:20 PM UTC

Sens. Mike Braun (R-Ind.), Lisa Murkowski (R-Alaska), and Martha McSally (R-Ariz.) Wednesday introduced legislation that would create a provisional approval pathway for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions.

The Promising Pathway Act (S. 3872) seeks to establish a mechanism for drug sponsors to receive rolling review of applications for drugs and biological products and for FDA to approve medicines on a time-limited basis. ...