FDA to allow expedited review of new 'sole-source' generic drugs

Mar 15, 2016 - 03:50 PM

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.

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