FDA Guideline "Advanced Manufacturing Technologies Program" published as a Draft

The FDA defines advanced manufacturing as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of the manufacturing and supply chain. This may involve new medicinal products or those already on the market, biomolecules such as small molecules.

The FDA encourages early adoption of such advanced manufacturing technologies (AMTs) to support a robust supply of medicinal products that are life-supporting, life-sustaining, of critical importance to health care, or in shortage. AMTs can directly improve product quality (e.g. through better control of the manufacturing process and less human intervention).

The new guidance document provides recommendations for participation in the FDA's Advanced Manufacturing Technologies programme. The document describes the eligibility criteria for AMT designation, the process for submitting and evaluating applications, and the benefits of AMT designation. In addition, it includes a comprehensive Q&A section that provides further details that are important for using the AMT programme.

In particular, the document describes:

  • The process for applying for AMT designation, including a description of the eligibility criteria and the data and other information to be included.
  • When and how the FDA evaluates AMT applications.
  • The process by which the FDA will contact holders of designated AMTs and applicants.
  • Potential benefits for medicinal product development and the evaluation of applications

The draft guidance document "Advanced Manufacturing Technologies Designation Program" can be commented on until 13 March.

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