Platform Technology Designation Program for Drug Development

Issue Date: May 28, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s):
Status: Draft

Platform Technology Designation Program for Drug Development

This guidance provides details about the implementation of the platform technology designation program established by section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss a planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This program is intended to result in efficiencies in drug development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies.

Download the Guidance Document

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