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US FDA Special Protocol Assessment Draft Guidance Adds Biosimilars But Not Much Clarity

This article was originally published in SRA

Executive Summary

Revisions proposed by the US Food and Drug Administration to its guidance on special protocol assessments (SPAs) reiterate that the agency is not bound by these agreements on the design and size of clinical trial programs. In addition, they clarify for the first time the situations in which the agency may revoke an agreement.

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