> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Platform Technology Designation Analyzed
- URL: https://www.fdaweb.com/fda-platform-technology-designation-analyzed/
- Published: 2024-06-12T12:00:00.000Z
- Updated: 2026-09-14T14:33:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157164

Two Morgan Lewis attorneys say a recent FDA draft guidance describing how it intends to implement the Platform Technology Designation Program “marks a continuation and expansion of efforts by Congress and FDA related to advanced manufacturing….” In an online [post](https://www.jdsupra.com/legalnews/fda-issues-draft-guidance-on-its-new-8167227/?ref=fdaweb.com), the attorneys say the law and guidance define a platform technology as a “well-understood and reproducible technology, such as a nucleic acid sequence or delivery method that **(1)** is essential to a drug, **(2)** can be adapted for or otherwise used by multiple drugs that share common structural elements, and **(3)** facilitates the manufacture or development of multiple drugs through a standardized process.”

The analysis says drug sponsors who are granted a platform technology designation may have access to these benefits:

- engaging in early interactions with FDA to discuss the use of a platform technology;
- leveraging data, when appropriate, from a prior product that used the designated platform technology;
- leveraging certain nonclinical safety data, when appropriate, from prior products that used the designated platform technology; and
- considering previous inspectional findings by FDA for subsequent marketing applications related to the manufacture of a drug that incorporates or uses the designated platform technology.

The program is available to sponsors of drugs or biologics already approved under an ANDA, NDA, or BLA that incorporates or uses a platform technology. Only technologies that FDA has determined qualify as a platform technology are eligible for platform technology designation, the agency says.