About Special Protocol Assessment (SPA)An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. For further information regarding the SPA process, please visit the FDA website, www.fda.gov. An SPA agreement is not a guarantee of approval, and there are no assurances that the design of, or data collected from, the planned bucindolol clinical trial will be adequate to obtain the requisite regulatory approvals for the marketing of bucindolol.
ARCA Announces Special Protocol Assessment Agreement With FDA For Bucindolol Development In Genotype-Defined Heart Failure Population
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