⚙️FDA Guidance on Advanced Manufacturing Technologies for Pharmaceuticals
Advanced Manufacturing Technologies Designation Program; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Advanced Manufacturing Technologies Designation Program." FDA encourages the early adoption of advanced manufacturing technologies (AMTs) by the pharmaceutical industry, which can improve the reliability and robustness of the manufacturing process and can benefit patients by enhancing product quality and reducing drug development time or increasing or maintaining the supply of drugs that are life-supporting, life-sustaining, of critical importance to providing health care, or in shortage. 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. The guidance finalizes the draft guidance of the same title issued on December 13, 2023.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
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The guidance encourages the adoption of advanced manufacturing technologies in the pharmaceutical industry, potentially leading to improvements in drug quality and supply. This can impact business processes and competitiveness for companies involved in drug manufacturing, which is emphasized in the summary and supplementary information.