The Fast Track to Drug Approval: Five FDA Pathways for Expedited Review

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The Fast Track to Drug Approval
Five FDA Pathways for Expedited Review

Increasing the speed of approval for drugs and therapies that address serious unmet medical needs — according to FDA Commissioner Gottlieb — is a top priority for the agency.

Passage of the 21st Century Cures Act and the most business-friendly climate in years has created a golden opportunity for Rx innovation.

But the tools aren’t just there for the taking. You have to understand how to use them ... what the FDA expects from you.

The FDA has established five application pathways that can get new products through review and onto the market more quickly and with fewer hoops to jump through.

The criteria for these pathways are stiff.  The drug or therapy must:

  • Address a serious condition — one that has substantial impact on day-to-day life
  • Aim to provide treatment or diagnosis of a serious condition that is not addressed adequately by available therapy, and
  • Be both approved or licensed in the U.S. for the same indication being considered for the new drug and relevant to current U.S. standards of care

The FDAnews report The Fast Track to Drug Approval outlines the five pathways — Fast-Track Designation, Breakthrough Therapy Designation, Regenerative Advanced Therapy Designation, Priority Review and Accelerated Approval. You’ll learn:

  • General criteria for applying under the expedited approval pathways
  • Key elements and requirements of each pathway
  • Content of submissions for each pathway
  • How to work with the FDA to increase chance of success
  • How to strategically align R&D functions with the expedited approval pathways.

The Fast Track to Drug Approval: Five FDA Pathways for Expedited Review provides you with an understanding of the five NDA submission programs that can cut approval time.

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Table of Contents

  • Introduction
  • Focus on Speed and Unmet Needs
  • Fast-Track Designation
  • Breakthrough Therapy Designation
  • And More …

View the entire TOC

Who Will Benefit

  • Director of Regulatory Affairs
  • In-house regulatory or legal counsel
  • Director of Clinical Operations
  • Chief Business/Development Officer

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