Special Protocol Assessment: Winning FDA Support for Trial Design

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Special Protocol Assessment
Winning FDA Support for Trial Design

There are no “sure things” in the FDA drug application process — but one agency program can relieve a major worry that tends to keep applicants up at night.

Participating in the Special Protocol Assessment (SPA) program allows drug sponsors to come to a consensus with the FDA on clinical trial design early in the process, clearing a hurdle that stops many New Drug Applications and Biologics License Applications in their tracks.

When should you consider pursuing an SPA?

The new draft guidance gives drug sponsors detailed advice on how to take advantage of the SPA, explaining what kinds of trials are eligible, how the request and review process works, what to do if the FDA doesn’t agree with your plans and how to handle changes to SPA-approved protocols.

The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information, such as:

  • When and how to request a SPA meeting
  • What types of trials are eligible for SPA consideration
  • Contents of a SPA request
  • How the FDA evaluates a SPA submission
  • What to do if the FDA rejects your trial protocol
  • How to modify a SPA agreement once a trial has started
  • When the FDA may rescind a SPA agreement
  • How to dispute the agency’s conclusions

Order your copy of this management report for a thorough understanding of the FDA’s SPA process and its benefits.

PDF Edition

Available Format

PDF Edition — $397

Who Will Benefit

  • Principal investigators
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Clinical Trial Regulatory Management
  • Global Clinical Safety and Pharmacovigilance Officers

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