Description
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 The guidance finalizes the draft guidance of the same title issued on December 13, 2023.
Scope & Applicability
Product Classes
2A category of drugs where interactions typically occur under user fee meeting types.
incorporation by reference of DMF for nonbiological parts
Stakeholders
9Entities eligible to request AMT designation
CBER Advanced Technologies Team
Emerging Technology Team within CDER
Entities eligible to request AMT designation
Persons submitting drug applications using designated AMTs
Persons or organizations seeking designation of a method of manufacturing; Entity that has developed a technology and submitted an AMT designation request.
Entity that has received AMT designation
entity submitting marketing applications
Person or organization whose AMT designation request has been granted.
Regulatory Context
Attributes
3Specified purpose and manner of use for a designated AMT; The particular conditions or parameters under which the AMT will be used; The specific manufacturing process and drug type for which an AMT is designated.
Difference between AMT, ETT, and CATT programs
Statutory prerequisite for AMT designation
Identified Hazards
Hazards
2AMTs support supply of drugs in shortage
Drugs on the shortage list under section 506E
Related CFR Sections (7)
- 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.
(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR314.420§ 314.420 Drug master files.
(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →
See Also (8)
- Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry (Status: Final)
- Cross-Center Master Files: Where to Submit: Draft Guidance for Industry (Status: Draft)
- Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry (Status: Final)
- Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff (Status: Final)
- Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Cellular Therapy for Cardiac Disease: Guidance for Industry (Status: Final)
- How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
- User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (Status: Final)