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# Final Guidance on Special Protocol Assessments
- URL: https://www.fdaweb.com/final-guidance-on-special-protocol-assessments/
- Published: 2018-04-13T12:00:00.000Z
- Updated: 2026-09-14T23:59:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141214

FDA has finalized a guidance on [Special Protocol Assessment (SPA) ](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM498793.pdf?ref=fdaweb.com)that provides drug manufacturers with information about the procedures and policies adopted by CDER/CBER for reaching an agreement on the design and size of certain clinical trials that could support marketing approval. “An SPA agreement indicates concurrence by the FDA with the adequacy and acceptability of critical elements of the overall protocol design that are important to ensuring that the trial conducted under that protocol has the potential to support the product’s approval,” the agency says. “This process can also allow sponsors and the FDA to agree on innovative clinical trial designs and novel endpoints for pivotal trials that, if successful, can provide templates for future research. These interactions ensure that the FDA agrees with key protocol elements and help sponsors plan late phase development.”

  
Additionally, FDA says the SPAs help make application reviews more efficient because submitted data are more likely to have already met certain criteria to support safety and efficacy. “The SPA process can also help avoid the conduct of trials that will not be able to provide evidence that could support drug approval, making clinical research more efficient,” it adds.