Advanced manufacturing is a general term for an innovative pharmaceutical manufacturing approach or technology that has the potential to improve the reliability and robustness of the manufacturing process and supply chain and increase timely access to quality medicines. Advanced manufacturing can integrate novel technological approaches, use established techniques in an innovative way, or apply production methods in a new domain where there are no defined best practices or experience.
FDA encourages the early adoption of specific advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drugs.3 These technologies can be integral to ensuring quality and supporting a robust supply of drugs that are life-supporting, life-sustaining, of critical importance to providing health care, or in shortage. AMTs can directly improve product quality (e.g., through better manufacturing controls and fewer human interventions).
This guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which facilitates the development of drugs manufactured using an AMT that has been designated as such under the program (hereinafter designated AMT). The guidance outlines the eligibility criteria for AMT designation, the submission and assessment process for requests, and the benefits of receiving an AMT designation and includes a questions and answers section to cover additional details about key concepts important for program utilization. Specifically, the guidance describes:
•The process for submitting an AMT designation request, including a description of eligibility criteria and the data and other information to be included.
• When and how FDA will assess AMT designation requests.
• The process by which FDA will engage with requestors, holders of designated AMTs, and applicants for drugs manufactured using, referencing, or relying upon a designated AMT.
• Benefits related to drug development and application assessment.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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