FDA guidance details new advanced manufacturing technology designation program

The US Food and Drug Administration (FDA) this week issued draft guidance detailing its new advanced manufacturing technologies (AMT) designation program, offering insights on submitting designation requests, agency communications and how the agency will engage with designation holders. FDA said it will expedite the development and assessment of applications and supplements that receive the designation.

The guidance outlines the eligibility criteria, the procedures for submitting designation requests, how FDA will assess designation requests and communicate with sponsors on applications.

The omnibus spending bill approved by Congress in December 2022 required FDA to establish an AMT program for manufacturing methods that incorporate a novel technology or use an established technology in a unique way to produce a drug of equivalent or superior drug quality; and required FDA to establish the program within one year of the law’s enactment. (RELATED: Omnibus brings new advanced manufacturing programs to FDA, Regulatory Focus 11 January 2023).

FDA announced that “use of designated AMTs can provide greater assurance of quality, shorten drug development time, increase or maintain the supply of drugs that are life-supporting, life-sustaining, or of critical importance to providing health care, assist stakeholders in more efficiently meeting regulatory requirements for commercial manufacturing, and strengthen regulatory predictability for products.”

A key benefit of the program is it allows early interaction between requestors and FDA for developing drugs under a designated AMT. Also, FDA expects to prioritize applicant interactions for discussing a designated AMT in drug development or commercial manufacturing.

Designation requests should include the following information:

·         A description of the manufacturing method and why it should be considered for AMT designation, including an explanation of how the method incorporates a novel technology or uses an established technology in a novel way;

·         A description of the method of manufacturing and why it should be considered for AMT designation;

·         A description of how the manufacturing method meets the eligibility criteria in a particular context of use. This description should outline the steps of the proposed AMT, and address where the AMT is to be used in the manufacturing process; 

·         The regulatory and technical challenges to implementing the proposed AMT; and

·         For a proposed AMT that is intended to manufacture an existing drug, sponsors should cross-reference to the existing application, and submit data demonstrating that the proposed AMT will increase or maintain the supply of the drug and maintain equivalent or superior drug quality.

A team of FDA experts from the center with jurisdiction over the drug will review the request and determine eligibility. The team will also seek input from subject matter experts to determine eligibility.

FDA recommends that applicants consult with CDER’s Emerging Technology Team (ETT) or CBER’s Advanced Technologies Team (CAT) before submitting an AMT designation request. These meetings can be useful for applications with less mature technologies or those with hypothetical processes, said FDA.

In a question-and-answer section, FDA explains the differences between the AMT designation programs and CDER’s ETP and CBER’s CAT. FDA explains that AMT designation requests are limited to manufacturing methods, while ETT and CATT can involve other features such as novel dosage forms or drug delivery systems.

The guidance was developed with stakeholder feedback from a June meeting on advanced manufacturing.

The deadline for submitting comments is 12 February 2024.

Draft guidance