The FDA Clinical Submission Survival Manual
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A regulatory submission is one time when the data don’t speak for themselves—and it’s no time to make mistakes. The FDA Clinical Submission Survival Manual provides a roadmap to help companies prepare a clear, succinct, high-quality submission, which persuasively communicates the benefit-risk within the clinical summaries of the NDA, BLA, or PMA. The Manual focuses on helping sponsors with this critical point in product approval, in which all subsequent communications with the FDA will be based. This book is organized to follow 3D Communications’ 3D A-C-T® process, Analysis – Content Development – Testing—to systematically identify and address potential issues and increase the chance for timely FDA approval. Specifically, it is designed to help teams improve objectivity, enhance regulatory interactions, clarify clinical communications, and align clinical data with the team’s goals.