FDA to allow expedited review of new 'sole-source' generic drugs
AHA News Now
Mar 15, 2016
The Food and Drug Administration Friday updated its policies and procedures for review of generic drugs to allow expedited review of applications for new “sole-source” generic drug products. These are drugs for which there is only one approved generic equivalent for a brand-name drug. The House Committee on Oversight and Government Reform last month held a hearing examining the recent surge in prices for such drugs.
Topic: Advocacy and Public Policy
Tags: Drug Shortages, drug prices