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# Stakeholders’ Views on FRAME
- URL: https://www.fdaweb.com/stakeholders-views-on-frame/
- Published: 2023-10-31T12:00:00.000Z
- Updated: 2026-09-14T14:14:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155681

Stakeholders have provided comments to FDA through a 10/14/22 discussion paper and 11/14-16/22 public workshop on the agency’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to foster a regulatory framework to support the adoption of advanced manufacturing technologies that could benefit patients. An agency [report](https://www.fda.gov/media/173449/download?ref=fdaweb.com) contains the stakeholder feedback and a follow-up action plan.

The report says stakeholders generally:

- identified areas in which they seek additional regulatory clarity about distributed manufacturing (DM) technologies for drugs and biological products;
- seek assurance that regulations and policies are compatible with DM strategies for drugs and biological products;
- seek clarified regulatory expectations to facilitate the implementation of DM for drugs and biological products; and
- seek international harmonization on the regulation of DM technologies to facilitate the adoption of DM for drugs and biological products.

The report says the agency action plan and actions taken thus far align with the four FRAME priorities — **(1)** seek and receive input; **(2)** address risks to ensure that regulations and policy are compatible with future advanced manufacturing technologies; **(3)** clarify expectations for stakeholders implementing advanced manufacturing; and **(4)** harmonize regulatory approaches.