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# Platform Technology Designation Guidance
- URL: https://www.fdaweb.com/platform-technology-designation-guidance/
- Published: 2024-05-28T12:00:00.000Z
- Updated: 2026-09-14T14:31:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157070

FDA has published a draft guidance, *Platform Technology Designation Program for Drug Development*, with details about the implementation of the platform technology designation program that was enacted as part of the 2023 Consolidated Appropriations Act. The agency says the [document](ttps://www.fda.gov/media/178928/download) outlines eligibility factors for receiving a platform technology designation, how to leverage data from designated platform technologies, how to discuss a planned designation as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request.

The agency says the guidance outlines how a well-understood and reproducible technology in an FDA-approved drug or biological product may be eligible for a platform technology designation. "There are several potential benefits for a drug company that receives a platform technology designation, including having early and additional interactions with FDA to discuss the use of a platform technology and leveraging information previously submitted in support of the designation in subsequent submissions from the same sponsor, such as new drug or biologics license applications," it says.

“This program is intended to result in efficiencies in drug development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies,” the draft says.