CMC Workspace
Decisions and descriptions for early CMC planning.
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Deliverables
Define Target Product Profile (TPP)
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Linked:Jurisdiction & Regulatory DesignationProgram Eligibility & Regulatory Pathway ConfirmationDevelop Critical Quality Attribute (CQA)Module 3 preparation
Description
The Target Product Profile (TPP) outlines the intended clinical attributes of the product. FDA-recommended framework for product planning per FDA Guidance for Industry: Target Product Profile — A Strategic Development Process Tool (2007) and maps to the Common Technical Document (CTD) Modules 2 and 5.
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