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# Change Platform Technology Guidance: Stakeholders
- URL: https://www.fdaweb.com/change-platform-technology-guidance-stakeholders/
- Published: 2024-08-27T12:00:00.000Z
- Updated: 2026-09-14T14:39:42.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5157658

Three stakeholders are recommending changes to an FDA draft guidance on the agency’s platform technology designation program. The National Organization for Rare Disorders (NORD) says the platform technology designation “is a promising regulatory tool of significant potential value to the rare disease community.” It [suggests](https://www.regulations.gov/comment/FDA-2024-D-1829-0027?ref=fdaweb.com) ways to improve the draft:

- provide additional clarity about the agency’s eligibility criteria for the platform technology designation program;
- create greater clarity, transparency, and predictability about the benefits associated with an approved designation;
- emphasize patient engagement and the inclusion of patient perspectives throughout the guidance and ensure appropriate formal and informal engagement of the rare disease community;
- consider ways to leverage some of the benefits associated with platform designation earlier in the drug development process, potentially before a predicate drug receives FDA approval or licensure;
- create transparency and trust by reporting adoption of the designation program and agency progress; and
- place greater emphasis on leveraging prior knowledge, findings, and proven best practices in the platform designation program.

The Biotechnology Innovation Organization(BIO) [says](https://www.regulations.gov/comment/FDA-2024-D-1829-0029?ref=fdaweb.com) it believes the program could provide opportunities for early and continuous engagement with the agency that can streamline drug development. It shares comments and proposed modifications under these topics:

- creating efficiencies to support innovation;
- preliminary evidence;
- potential benefits;
- inclusion of non-clinical and clinical data
- consistency across product types and language use;
- rejection of application;
- early guidance and submission requirements; and
- general questions/clarifications.

BIO also submits line-by-line specific comments.

The International Society for Pharmaceutical Engineering [says](https://www.regulations.gov/comment/FDA-2024-D-1829-0030?ref=fdaweb.com) the guidance would benefit from allowing platform technology designation to have broader eligibility criteria, such as covering medical devices and a greater range of small and more conventional technologies such as monoclonal antibody biologic product technologies. It also submits detailed line-by-line comments.