Sec. 105. Advanced manufacturing technologies program
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Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by adding at the end the following: Not later than 1 year after the date of enactment of the Manufacturing API, Drugs, and Excipients in America Act , the Secretary shall continue in effect the programs to facilitate the development and review of an application under subsection
(b)or
(j)of section 505 of this Act or subsection
(a)or
(k)of section 351 of the Public Health Service Act for a drug or biological product that is manufactured using one of more advanced manufacturing technologies that have been designated in accordance with subsection (b). The Secretary shall designate a method of manufacturing or development of a drug or biological product as an advanced manufacturing technology under this section if it incorporates a novel technology or uses an established technique or technology in a novel way that— enhances drug quality; or improves the flexibility, robustness, or efficiency of the manufacturing process to— prevent or resolve a drug shortage; reduce premarket development time; or increase the supply of drugs described in paragraph
(1)or
(2)of section 506C(a) for national emergencies. If the Secretary designates a method of manufacturing as an advanced manufacturing technology under this section, the Secretary shall take actions to expedite the development and implementation of such method of manufacture for purposes of approval of an application under subsection
(c)or
(j)of section 505 of this Act or subsection
(a)or
(k)of section 351 of the Public Health Service Act, which may include, as appropriate, holding meetings between the sponsor of the application and appropriate Food and Drug Administration staff throughout the development of the drug of biological product using such advanced manufacturing technology. A person who seeks designation of an advanced manufacturing technology under this section shall submit to the Secretary a package of scientific evidence supporting the implementation of the advanced manufacturing technology in a particular context-of-use. The Secretary shall assist with the development of such package by— providing timely advice to, and interactive communication with, the sponsor regarding the development of the technology; and involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing. Within 90 days of receiving a package under paragraph (1), the Secretary shall determine whether a designated advanced manufacturing technology is validated for the proposed context of use based on the scientific merit the supporting evidence provided by the sponsor. Upon designation of an advanced manufacturing technology, the holder of the advanced manufacturing technology designation, or a person the advanced manufacturing technology designation holder authorizes, may rely upon the advanced manufacturing technology for use across multiple manufacturing or product lines within the same context-of-use without having to re-submit data to the Secretary validating the underlying technology. The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 1 year after the date of enactment of the Manufacturing API, Drugs, and Excipients in America Act , to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of, and a suitable framework and procedures and requirements for, the program under this section. The Secretary shall— not later than 1 year after the date of enactment of the Manufacturing API, Drugs, and Excipients in America Act , issue draft guidance regarding the goals and implementation of the program under this section; and not later than 2 years after the date of enactment of the Manufacturing API, Drugs, and Excipients in America Act , issue final guidance with respect to the implementation of such program. The Secretary shall make available on the public website of the Food and Drug Administration an annual report on the progress of the programs under this section. .
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Sec. 105
Advanced manufacturing technologies program
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