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The new draft guidance gives drug sponsors detailed advice on how to take advantage of the SPA, explaining what kinds of trials are eligible, how the request and review process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The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information, such as: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 — $397
Who Will Benefit
Director of Clinical Operations
Regulatory Affairs Professionals
Director of Clinical Trial Regulatory Management
Global Clinical Safety and Pharmacovigilance Officers
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.