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What is FDA guidance on protocol?

FDA Issues Guidance on Comparability Protocols. In the guidance, FDA establishes a framework to improve quality by encouraging applicants to effectively use knowledge of the manufacturing process, have a robust control strategy, perform risk-management activities over a product’s lifecycle, and have an effective quality system.

What is Special Protocol Assessment?

A Special Protocol Assessment (SPA) is an advanced declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval.

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