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# 3 FDA Innovative Manufacturing Action Steps
- URL: https://www.fdaweb.com/3-fda-innovative-manufacturing-action-steps/
- Published: 2024-09-11T12:00:00.000Z
- Updated: 2026-09-14T14:40:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157754

As required by the PDUFA 7 reauthorization agreement, FDA has issued its draft strategy document outlining the specific actions it will take over the course of PDUFA 7 (2023-2027) to facilitate the use of innovative manufacturing technologies, including addressing barriers to their adoption. The [document](https://www.fda.gov/media/181689/download?attachment&ref=fdaweb.com) says the actions are based on lessons learned from the agency’s experiences with submissions involving advanced manufacturing technologies, as well as feedback from a 6/8/2023 public workshop and other public input.

The actions the agency says it will take are to:

- continue to enhance the emerging technology program and CBER advanced technologies team as mechanisms to support innovation;
- support and utilize ongoing initiatives for advanced manufacturing to address potential barriers; and
- implement the Advanced Manufacturing Technology Designation Program.