The program described in today’s final guidance “Advanced Manufacturing Technologies Designation Program” offers a framework for drug companies and organizations to request a drug manufacturing method be designated as an advanced manufacturing technology (AMT). Under this program, FDA will expedite development and assessment of applications for drugs that are manufactured using a designated AMT. 

This guidance finalizes the draft guidance of the same title issued on December 13, 2023. FDA considered comments received on the draft guidance and in response made changes to the final guidance including clarifying:   

• the AMT designation process,
• the information that should be included in an AMT designation requests,
• the roles and responsibilities of various entities that might be involved in the development and use of designated AMTs, and
• the relationship between the Advanced Manufacturing Technologies Designation Program and other FDA programs addressing emerging or advanced technologies.

FDA will provide notification when this guidance receives approval for full implementation. The agency continues to accept requests for AMT designation ..[FDA]