Department of Health and Human Services January 2, 2025 – Federal Register Recent Federal Regulation Documents

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 The guidance finalizes the draft guidance of the same title issued on December 13, 2023.

Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA), that a meeting of the National Advisory Committee on the Trafficking of Children and Youth in the United States (Committee) will be held on January 13, 2025. The purpose of the meeting is for the Committee to discuss its plans and responsibilities over its 24-month extension to advise on the development and implementation of successful interventions with children and youth who have been impacted by labor and sex trafficking, make recommendations for administrative and legislative changes regarding the trafficking of children and youth, and publish information on best practices regarding the labor and sex trafficking of children and youth.