FDA Guidance for Expedited Programs For Serious Conditions

FDA updates guidelines to expedite the development and review of new drugs.

The FDA just released its guidance for industry regarding expedited programs for serious conditions. There are four FDA programs intended to expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition. They are: 1) fast track designation, 2) breakthrough therapy designation, 3) accelerated approval, and 4) priority review designation.

Fast Track Designation

Drug to treat a serious disease and fill an unmet medical need.

Key Points

• Designation may be granted on the basis of preclinical or clinical data
• Process designed to facilitate development and expedite review
• Fast Track designated drugs are eligible for: More frequent interactions with FDA (meetings or written correspondence) during drug development Rolling review, whereby companies can submit completed sections of marketing applications for FDA review, rather than waiting until every section is complete

Breakthrough Therapy Designation

Drug intended to treat a serious or life-threatening disease in which there is currently a treatment available.

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