Advanced 
Manufacturing 
Technologies 
Designation Program 
Guidance for Industry 
 
 
 
 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments to https://www.regulations.gov. Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Ranjani Prabhakara 240-402-4652, 
or (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-
8010.  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
December 2023 
Pharmaceutical Quality/CMC 
   
Advanced 
Manufacturing 
Technologies 
Designation Program 
Guidance for Industry 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances  
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
 December 2023 
Pharmaceutical Quality/CMC 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  AMT DESIGNATION REQUESTS ............................................................................... 3 
A.  Criteria ............................................................................................................................................ 3 
B.  Content of the Request .................................................................................................................. 4 
C.  Submission Process ........................................................................................................................ 5 
D.  Designation Determination ........................................................................................................... 6 
E.  Lifecycle .......................................................................................................................................... 6 
IV.  POTENTIAL BENEFITS OF AMT DESIGNATION .................................................. 7 
A.  Drug Development ......................................................................................................................... 9 
B.  Application Assessment ................................................................................................................. 9 
V.  QUESTIONS AND ANSWERS ....................................................................................... 9 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Advanced Manufacturing Technologies Designation Program 
2  Guidance for Industry1 
3   
4   
5  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
6  Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 
7  binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 
8  applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 
9  for this guidance as listed on the title page.  
10   
11   
12   
13   
14  I.  INTRODUCTION  
15   
16  Advanced manufacturing is a term for an innovative pharmaceutical manufacturing technology 
17  or approach that has the potential to improve the reliability and robustness of the manufacturing 
18  process and supply chain and increase timely access to quality medicines for the American 
19  public. Advanced manufacturing can integrate novel technological approaches, use established 
20  techniques in an innovative way, or apply production methods in a new domain where there are 
21  no defined best practices or experience. Advanced manufacturing can potentially be used for new 
22  or currently marketed small molecule drugs or biological products. 
23   
24  FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have 
25  the potential to benefit patients by improving manufacturing and supply dependability and 
26  optimizing development time of drug and biological products. These technologies can be integral 
27  to ensuring quality and supporting a robust supply of drugs that are life-supporting, life-
28  sustaining, of critical importance to providing health care, or in shortage. AMTs can directly 
29  improve product quality (e.g., through better manufacturing controls and fewer human 
30  interventions).  
31   
32  This guidance provides recommendations to persons and organizations interested in participating 
33  in FDAs Advanced Manufacturing Technologies Designation Program, which is intended to 
34  facilitate the development of drugs, including biological products, manufactured using an AMT 
35  that has been designated as such under the program (hereinafter designated AMT). The guidance 
36  outlines the eligibility criteria for AMT designation, the submission and assessment process for 
37  requests, and the benefits of receiving an AMT designation and includes a questions and answers 
38  section to cover additional details about key concepts important for program utilization. 
39  Specifically, the guidance describes: 
40   
 
1 This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and 
Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug 
Administration.  
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
41    The process for submitting an AMT designation request, including a description of 
42  eligibility criteria and the data and other information to be included. 
43   
44    When and how FDA will communicate receipt of and provide advice on an AMT 
45  designation request. 
46   
47    When and how FDA will assess AMT designation requests. 
48   
49    The process by which FDA will engage with holders of designated AMTs and applicants 
50  for drugs manufactured using, referencing, or relying upon a designated AMT.2  
51   
52    Potential benefits related to drug development and application assessment.3 
53   
54  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
55  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
56  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
57  the word should in Agency guidances means that something is suggested or recommended, but 
58  not required.  
59   
60   
61  II.  BACKGROUND 
62   
63  FDAs Advanced Manufacturing Technologies Designation Program, which is required under 
64  section 506L of the Federal Food, Drug, and Cosmetic Act (FD&C Act),4 offers a framework for 
65  persons or organizations (e.g., applicants, contract manufacturers, technology developers) to 
66  request designation of a method or combination of methods of manufacturing5 a drug6 as an 
67  AMT. The program is intended to facilitate the development of drugs that are manufactured 
68  using a designated AMT, submitted in an application under section 505 of the FD&C Act (21 
69  U.S.C. 355) or section 351 of the Public Health Service Act (PHS Act, 42 U.S.C. 262), and 
70  regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics 
71  Evaluation and Research (CBER). The holder of the AMT designation or another authorized 
72  party may reference or rely upon data or information about the designated AMT in an application 
73  in the same context of use for which the designation was granted.7 FDA will expedite 
 
2 In this guidance, the term applicant also refers to sponsors of investigational new drug applications. 
3 In this guidance, the term assessment also means review. Assessment is the term that the Center for Drug 
Evaluation and Researchs Office of Pharmaceutical Quality and Office of Generic Drugs will generally use in place 
of review. Assessment means the process of both evaluating and analyzing submitted data and information to 
determine whether the application meets the requirements for approval and documenting that determination. 
4 Section 3213 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) amended the FD&C Act, in part, to 
add section 506L, codified at 21 U.S.C.  356l. 
5 In this guidance, the term manufacturing includes the steps outlined in the definition of manufacture in 21 CFR 
207.1. 
6 In this guidance, the term drug refers to human drug products and biological products, and components of such 
products including active pharmaceutical ingredients, unless otherwise specified. 
7 See section 506L(c)(1) of the FD&C Act. In this guidance, context of use refers to the purpose and manner of use 
for a designated AMT that will be used in drug development and manufacturing. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
74  development and assessment of an application, including supplements, for drugs that are 
75  manufactured using a designated AMT as described in section 506L(d)(1) of the FD&C Act. 
76   
77  Use of designated AMTs can provide greater assurance of quality, shorten drug development 
78  time, assist stakeholders in more efficiently meeting regulatory requirements for commercial 
79  manufacturing, and strengthen regulatory predictability for products that use a designated AMT. 
80  To encourage the adoption of designated AMTs, FDA offers early engagement opportunities, 
81  before application submission, with persons or organizations seeking designation of a method of 
82  manufacturing as an AMT (hereinafter requestors), designated AMT holders, and applicants to 
83  advise on designated AMTs and their implementation in drug manufacturing.   
84   
85   
86  III.  AMT DESIGNATION REQUESTS 
87   
88  Requestors should familiarize themselves with the data requirements described in section 506L 
89  of the FD&C Act, the recommendations outlined in this guidance, and other publicly available 
90  sources of product development information8 before submitting an AMT designation request.  
91   
92  AMT designation requests are made independently of application submissions. Therefore, there 
93  is no predetermined stage of product development or specific application assessment cycle 
94  during which AMT designation requests can be submitted to FDA. Rather, requestors should 
95  submit their request when they have sufficient knowledge to support justification for AMT 
96  designation.  
97   
98  FDA strongly recommends that requestors engage with CDERs Emerging Technology Team 
99  (ETT) or CBERs Advanced Technologies Team (CATT), where appropriate, before submitting 
100  an AMT designation request. The ETT manages CDERs Emerging Technology Program and 
101  the CATT manages CBERs Advanced Technologies Program. Both programs assist companies 
102  interested in implementing emerging or advanced technologies in drug development and are 
103  suitable for less mature technologies, such as proof-of-concept or prototype systems or 
104  hypothetical processes that have not yet been developed.9 Early engagement with the ETT or 
105  CATT provides an initial opportunity to discuss a technology before it has reached a maturity 
106  level appropriate for AMT designation.  
107   
108  A.  Criteria  
109   
110  Per the criteria described in section 506L(b) of the FD&C Act, a method of manufacturing or 
111  combination of methods is eligible for AMT designation if it incorporates a novel10 technology 
112  or uses an established technique or technology in a novel way that will substantially improve the 
 
8 See, e.g., International Council for Harmonisation guidance for industry Q8(R2) Pharmaceutical Development 
(November 2009). We update guidances periodically. For the most recent version of a guidance, check the FDA 
guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
9 For information about ETT and CATT and how they differ from the Advanced Manufacturing Technologies 
Designation Program and these two other programs, see section V, Q5, in this guidance. 
10 For an explanation of how FDA interprets the term novel in the context of a technology or a use of that technology 
being considered for AMT designation, see section V, Q1. 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
113  manufacturing process for a drug while maintaining equivalent, or providing superior, drug 
114  quality, including by: 
115   
116    Reducing development time for a drug using the designated manufacturing method; or 
117   
118    Increasing or maintaining the supply of a drug that is life-supporting, life-sustaining, or 
119  of critical importance to providing health care, or a drug that is on the drug shortage list 
120  under section 506E of the FD&C Act (21 U.S.C. 356e). 
121   
122  Because FDA strongly recommends that requestors engage with the ETT or CATT before 
123  submitting an AMT designation request, the AMT for which they are seeking designation 
124  (hereinafter proposed AMT) should also generally meet the eligibility criteria described in 
125  CDERs Emerging Technology Program and CBERs Advanced Technologies Program.11 
126   
127  B.  Content of the Request 
128   
129  An AMT designation request must include data or information demonstrating that the method of 
130  manufacturing meets the statutory criteria in a particular context of use.12 In addition, the request 
131  must demonstrate the ability of the proposed AMT to substantially improve the manufacturing 
132  process for a drug while maintaining or improving upon its quality, including by reducing drug 
133  development time or increasing or maintaining the supply of a drug that is life-supporting, life-
134  sustaining, of critical importance to providing health care, or in shortage.13 The robustness of the 
135  data and information should be commensurate with the level of risk inherent to the process and 
136  potential product, such that the data and information can be later leveraged in a marketing 
137  application.  
138   
139  Specifically, an AMT designation request should include the following information: 
140   
141    A brief description of the method of manufacturing or combination of methods and why 
142  it should be considered for AMT designation, including a brief explanation of how the 
143  method, in part or in whole, incorporates a novel technology or uses an established 
144  technique or technology in a novel way. 
145   
146    A detailed description of how the method of manufacturing or combination of methods 
147  meets the eligibility criteria described in section 506L(b) of the FD&C Act in a particular 
148  context of use. This description should include: 
149   
150    An outline of the steps of the proposed AMT, including information about where in 
o
151  the overall manufacturing process the proposed AMT is intended to be used. 
152   
 
11 For the Emerging Technology Programs eligibility criteria, see https://www.fda.gov/about-fda/center-drug-
evaluation-and-research-cder/how-participate-etp. For the scope of the Advanced Technologies Program, see 
https://www.fda.gov/vaccines-blood-biologics/industry-biologics/cber-advanced-technologies-team-catt.  
12 Section 506L(c)(1) of the FD&C Act. 
13 Section 506L(b) of the FD&C Act. 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
153    A description of proposed process controls, quality information, and, if applicable, 
o
154  proposed controls of critical steps, intended to ensure equivalent or superior drug 
155  quality. 
156   
157    Developmental data and information for the proposed AMT that evaluates and 
o
158  justifies the context of use. 
159   
160    The context of use under which the proposed AMT will be used in drug development, 
161  including information (e.g., dosage form, class of drug) about a model (i.e., 
162  representative) drug used to generate data submitted in the request. 
163   
164    Perceived regulatory, technical, or other challenges to implementation of the proposed 
165  AMT.  
166   
167    The timeline, as applicable and if known at the time of the AMT designation request, for 
168  drug development activities that incorporate the proposed AMT, including the planned 
169  submission of any applications that would use, reference, or rely upon data and 
170  information about the proposed AMT in the same context of use. 
171   
172    If applicable, information about previous engagement with ETT/CATT. 
173   
174    For a proposed AMT that is intended for use in manufacturing an existing drug that meets 
175  the criteria in section 506L(b)(2)(A) or (B) of the FD&C Act: 
176   
177    A cross-reference to the existing application. 
o
178   
179    Data demonstrating that the proposed AMT will increase or maintain the supply of 
o
180  the drug and will maintain equivalent or provide superior drug quality. 
181   
182  FDA acknowledges that requestors who are not also applicants may not have data about a 
183  specific drug to include in their AMT designation request. In these cases, FDA recommends that 
184  requestors include data generated using a model drug to provide the Agency with a clear 
185  understanding of the proposed AMTs parameters, limitations, and context of use.  
186   
187  C.  Submission Process  
188   
189  Requestors should submit their AMT designation request electronically to 
190  AMT_designation_requests@fda.hhs.gov.14 The subject line should be REQUEST FOR AMT 
191  DESIGNATION in uppercase letters. In addition to the data and information described in section 
192  III.B of this guidance, the email should include the requestors contact information including the 

 
14 If the request includes confidential commercial information, it is the responsibility of the company to ensure it is 
submitted using one of FDAs secure messaging partners. Requestors can ask to be added to the list of FDAs secure 
messaging partners by emailing SecureEmail@fda.hhs.gov. Confidential commercial or trade secret information 
should be clearly marked as such in accordance with 21 CFR 20.61(d). 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
193  name, address, email address, and telephone number for their main point of contact and indicate 

194  if the request is specific to CDER, CBER, or both.  
195   
196  Upon receipt of the AMT designation request, FDA intends to acknowledge receipt and begin an 
197  evaluation to determine whether to designate the proposed AMT.  
198   
199  D.  Designation Determination 
200   
201  AMT designations will generally be limited to those methods of manufacturing that meet the 
202  criteria described in section 506L(b) of the FD&C Act and section III.A of this guidance. To 
203  determine eligibility, a team of FDA experts from the center with jurisdiction over the type of 
204  drug intended for development will review the request. This team, including members of the 
205  ETT or CATT, where applicable, will evaluate the data and information submitted in the request, 
206  including information relating to the context of use, and will seek input from subject matter 
207  experts, as needed, to determine if the proposed AMT meets the designation criteria and should 
208  therefore be granted AMT designation. For proposed AMTs that have potential cross-center 
209  impact, a cross-disciplinary team, including members from CDER and CBER, will evaluate the 
210  requests.15 
211   
212  The team will include a designated lead with demonstrated expertise in the manufacturing 
213  process, product type, or other elements specific to the proposed AMT to serve as the primary 
214  subject matter expert for the request. The designated lead may facilitate contact with the 
215  requestor to obtain additional information about the AMT designation request or to coordinate 
216  discussions with the team concerning specific aspects of the proposed AMT during the 
217  designation determination process.16 As appropriate, the designated lead will facilitate the 
218  involvement of senior FDA managers and other experienced FDA staff in a collaborative, cross-
219  disciplinary review of the proposed AMT.17 
220   
221  Section 506L(e)(2) of the FD&C Act requires FDA to complete AMT designation 
222  determinations regarding designation for a particular context of use and acceptance into the 
223  program in writing within 180 calendar days of FDAs receipt of the request.18 Submission of an 
224  AMT designation request does not guarantee designation or acceptance into the program. FDA 
225  expects to deny requests that are incomplete or submitted for methods of manufacturing that do 
226  not meet the criteria described in 506L(b) of the FD&C Act.  
227   
228  E.  Lifecycle 
229   
230  Designated AMT holders should communicate proposed changes to designated AMTs by 
231  emailing AMT_designation_requests@fda.hhs.gov. The subject line should be PROPOSED 
232  CHANGE FOR DESIGNATED AMT in uppercase letters. In addition to the requestors contact 
233  information described in section III.C of this guidance, the email should include the name of the 
 
15 See section 506L(c)(1) (B) of the FD&C Act. 
16 See section 506L(c)(1)(A) of the FD&C Act. 
17 See section 506L(c)(1)(B) of the FD&C Act. 
18 See section 506L(c)(2) of the FD&C Act. 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
234  designated lead on the original AMT designation request and the product center that reviewed 
235  the request (CDER, CBER, or both), a brief description of the proposed change, and a list of 
236  persons or entities who have been given a right of reference to the designated AMT. The email 
237  should also address the potential impact of the proposed change on: 
238   
239    Whether the designated AMT continues to meet the criteria for designation. 
240   
241    The particular context of use for which the AMT was designated, as defined at the time 
242  of initial designation. 
243   
244    Approved applications for products using, referencing, or relying upon the designated 
245  AMT. 
246   
247  FDA intends to assess the proposed changes, including data to support such changes, to confirm 
248  that the designated AMT continues to meet criteria for designation and to evaluate any potential 
249  impact on the particular context of use for which the AMT was designated. Applicants with 
250  approved applications that use, reference, or rely upon a designated AMT should evaluate the 
251  potential impact of the change on the finished product that is the subject of the application to 
252  determine whether a postapproval submission is required as described in 21 CFR 314.70 or 
253  601.12.19 
254   
255  Once FDA has gained significant experience assessing a designated AMT and the designated 
256  AMT has been used in multiple approved regulatory applications, FDA may decide to graduate 
257  the technology and transfer the review of future applications that use, reference, or rely upon that 
258  AMTincluding supplements to an original application that had previously been granted the 
259  designationto the standard quality assessment process (rather than an expedited process). 
260  Doing so would allow FDA to focus resources on new AMTs that continue to meet the 
261  programs goal of encouraging adoption of novel technologies to shorten drug development 
262  times for critical medicines while maintaining or improving product quality.  
263   
264   
265  IV.  POTENTIAL BENEFITS OF AMT DESIGNATION 
266   
267  A key benefit of the Advanced Manufacturing Technologies Designation Program is FDAs 
268  early interaction with requestors and applicants regarding the development of drugs that may be 
269  manufactured using a designated AMT.20 As resources permit, FDA intends to provide timely 
270  advice and to engage in additional communication, in the form of written correspondence or 
271  meetings, with requestors, designated AMT holders, and applicants for a drug manufactured 
272  using a designated AMT. Such communication may take place during both early drug 
273  development and subsequent application assessment and will be used to address proposed or 
274  designated AMT-related questions and issues, including AMT design or development issues, 
275  submission content related to a designated AMT, and other AMT-related topics. When 
 
19 To facilitate this evaluation, FDA recommends that entities that obtain a right of reference to reference or rely 
upon a designated AMT ensure the agreement includes mechanisms for communication regarding future changes. 
20 See sections 506L(c) and (d) of the FD&C Act. 
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
276  appropriate, this process may include coordination with the appropriate FDA quality assessment 
277  team. 
278   
279  FDA expects to prioritize applicant interactions that are intended to discuss the use of a 
280  designated AMT in drug development or commercial manufacturing, with higher priority being 
281  given to drug development activities and applications using a designated AMT with the potential 
282  to significantly improve product quality, address known quality issues for a drug or class of 
283  drugs, or increase or maintain the supply of drugs that are currently in shortage or imminently at 
284  risk of being in shortage. Consideration for prioritization may also be given to drug development 
285  activities and applications that are accepted into other expedited programs (e.g., fast track, 
286  breakthrough therapy). For NDAs, BLAs, and ANDAs involving complex generic drugs, these 
287  interactions typically occur under the appropriate user fee meeting type21 and are generally 
288  facilitated through the designated lead for the AMT request, in consultation with the application 
289  quality assessment team. Applicants should determine the frequency and timing of the meeting 
290  requests based on the stage of development of their drug. For ANDAs not involving complex 
291  generic drugs, these interactions would typically take place through controlled correspondence.22 
292  However, applicants with a designated AMTwhether the ANDA involves a complex product 
293  or a non-complex productcan also request product development and presubmission 
294  meetings.23 Any additional interaction deemed necessary by FDA will be communicated and 
295  facilitated by the designated lead for the AMT request. 
296   
297  Using existing tools and resources, the designated lead will communicate to the applicant advice 
298  and information relevant to product quality to support the successful adoption of a designated 
299  AMT. As needed, the designated lead will also connect applicants with other FDA disciplines 
300  outside the scope of product quality when an applicant requires expertise or advice from these 
301  other disciplines. 
302   
303  It is the applicants responsibility to demonstrate, through the required technical data submitted 
304  in the chemistry, manufacturing, and controls (CMC) section,24 that a designated AMT is 
305  suitable for inclusion in their application.  
306   
307     
 
21 See draft guidances for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA 
Products, Revision 1 (September 2023) and Formal Meetings Between the FDA and Sponsors or Applicants of 
BsUFA Products, Revision 1 (August 2023). When final, these guidances will represent FDAs current thinking on 
these topics. See also guidances for industry Formal Meetings Between FDA and ANDA Applicants of Complex 
Products Under GDUFA, Revision 1 (October 2022) and Expedited Programs for Regenerative Medicine Therapies 
for Serious Conditions (February 2019). 
22 See draft guidance for industry Controlled Correspondence Related to Generic Drug Development (December 
2022). When final, this guidance will represent the FDAs current thinking on this topic. 
23 Applicants should submit requests for a product development meeting in an appropriate format, such as the format 
described in the guidance for industry Formal Meetings Between FDA and ANDA Applicants of Complex Products 
Under GDUFA, Revision 1. In addition to the applicable information identified in sections V and VIII of the Formal 
Meetings guidance, applicants should provide documentation of the AMT designation. 
24 See 21 CFR 314.50(d)(1), 21 CFR 314.94(a)(9), and 21 CFR 601.2. 
  8  Contains Nonbinding Recommendations 
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308  A.  Drug Development 
309   
310  Applicants are encouraged to take advantage of the benefits afforded under the program to 
311  engage with the team that designated the AMT to discuss, early in the development process, how 
312  the designated AMT can be used to shorten or otherwise optimize drug development time.25 The 
313  designated lead will work to: 
314   
315    Ensure that meetings with the applicant are collaborative and productive.  
316   
317    Answer applicant questions about the information appropriate to be included in their 
318  application. 
319   
320    Discuss the quality assessment of future applications that plan to use, reference, or rely 
321  upon a designated AMT. 
322   
323  B.  Application Assessment 
324   
325  The designated lead will facilitate the quality assessment of an application for a drug 
326  manufactured using the designated AMT with the aim of making the assessment process more 
327  efficient than the process for applications using manufacturing methods not designated under the 
328  program. FDA intends to use this approach to support applicants while they are developing the 
329  CMC section of their applications such that the incorporation of a designated AMT will not 
330  increase the time or number of assessment cycles required to arrive at a quality-related decision 
331  and, as a result, will not increase the time required to arrive at a decision regarding overall 
332  application approval. When a designated AMT is used across multiple drugs, the knowledge and 
333  familiarity gained by FDA during assessment of the first application should streamline the 
334  assessment of subsequent applications that use the same designated AMT. 
335   
336  When a designated AMT no longer meets the eligibility criteria, as described in section III.E of 
337  this guidance, appropriate steps will be followed to transfer information about the previously 
338  designated AMT to the appropriate assessment team for applications that used, referenced, or 
339  relied upon the previously designated AMT. New applications received after the transfer occurs 
340  will be eligible for the standard level of FDA communication and interaction that the application 
341  would otherwise receive.  
342   
343   
344  V.  QUESTIONS AND ANSWERS 
345   
346  Q1.  What does FDA consider a novel technology or use of an established technique or 
347  technology in a novel way? 
348   
349  For purposes of evaluating eligibility for AMT designation, FDA generally considers a novel 
350  technology to be one that has not been used in a previously approved application and for which 
351  FDA therefore has limited assessment or inspectional experience. Similarly, FDA generally 
 
25 See section V, Q7, in this guidance for information about requesting engagement. 
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352  considers an established technique or technology to be novel if it is used in a way that has not 
353  been described in a previously approved application. It is important to note that certain 
354  technologies or their uses may be considered novel but play such a limited role in the 
355  development or manufacture of a particular drug that their incorporation would not qualify the 
356  method of manufacturing for AMT designation. In such cases, the method of manufacturing 
357  would not meet the eligibility criteria for designation because, given its limited role, the novel 
358  technology or novel use that is incorporated would not be considered to substantially improve the 
359  manufacturing process for a drug.  
360   
361  Q2.  How is context of use considered when determining AMT designation and assessing 
362  applications for other products (i.e., not the model drug used for the AMT designation 
363  request)?  
364   
365  Consistent with section 506L(c) of the FD&C Act, AMT designation applies to a method of 
366  manufacturing within a particular context of use rather than to a specific application. 
367  Nevertheless, the data and information necessary to support an AMT designation request should, 
368  at a minimum, be specific to a particular class of drugs and, as described in section III of this 
369  guidance, should include development data, including batch analysis data generated using either 
370  a developmental candidate molecule or a model drug. 
371   
372  Requestors should fully and clearly describe the context of use within which they are requesting 
373  the AMT be designated, including how it will be used to develop and manufacture a specific type 
374  or range of drugs. Requestors can contact their designated lead to request an update to the 
375  context of use for a designated AMT when additional supportive data become available (e.g., 
376  additional batch analysis data from additional products). FDA will determine on a case-by-case 
377  basis whether to update the context of use (e.g., the scope of drugs to be manufactured using the 
378  designated AMT) for the designated AMT as proposed by the requestor or if additional data are 
379  necessary to support the expanded designation request.  
380   
381  Whether the use of a designated AMT for manufacturing a specific drug that is the subject of an 
382  application would be considered to be the same context of use for which the AMT was 
383  designated can be discussed in presubmission meetings and will be determined during the 
384  application assessment process. 
385   
386  Q3.  How can an applicant reference or rely upon a designated AMT in an application? 
387   
388  When an applicant and designated AMT holder are different entities, the designated AMT holder 
389  can authorize the applicant to incorporate by reference data and information about the designated 
390  AMT in their application. In some cases, the designated AMT holder may also be the holder of a 
391  drug master file (DMF) that contains the designated AMT.26 In those circumstances, an applicant 
392  submitting an NDA or ANDA can, to support their application and with an appropriate right of 
393  reference, generally reference a DMF. However, when a DMF holder is also the holder of a 
394  designated AMT, information specifically describing the designated AMT should be shared with 
395  the NDA or ANDA applicant. An application that references or relies upon a designated AMT 
 
26 See 21 CFR 314.420. 
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Draft  Not for Implementation 
396  can receive the benefits provided by the AMT designation with the appropriate authorization if 
397  the referenced AMT is used to manufacture a drug in the same context of use for which the 
398  designation was granted as described above.  
399   
400  Although multiple applications can reference the same designated AMT, each application 
401  referencing a particular designated AMT will be assessed on its own merits. When referencing or 
402  relying upon a designated AMT in an application, applicants should explain how the designated 
403  AMT will be used to manufacture the drug that is the subject of the application and why that 
404  context of use is consistent with the context of use for which the AMT received designation. 
405   
406  Q4.  How can designated AMTs be used, referenced, or relied upon in a BLA as 
407  compared to an NDA or ANDA?  
408   
409  Because AMT designation is granted outside the context of a specific application, a designated 
410  AMT can support a small molecule drug or biological product. Because a BLA holder is 
411  expected to have knowledge of and control over the manufacturing process for the biological 
412  product for which it has a license, FDA generally expects such information to be submitted 
413  directly to the BLA.27 For this reason, the BLA applicant should have access to the supportive 
414  data and information for drug substance, drug substance intermediate, and drug product 
415  manufacturing relevant to the AMT and should not incorporate by reference a designated AMT, 
416  including by referencing a DMF that contains a designated AMT.  
417   
418  Q5.  How does the Advanced Manufacturing Technologies Designation Program differ 
419  from CDERs Emerging Technology Program and CBERs Advanced Technologies 
420  Program? 
421   
422  All three programs focus on early engagement between FDA and prospective developers of 
423  CDER- or CBER-regulated products to discuss potential regulatory challenges and clarify related 
424  questions. CDERs Emerging Technology Program allows potential applicants, before 
425  application submission, to submit questions and proposals about the use of a specific emerging 
426  technology to the ETT, a group that serves as the primary point of contact for companies 
427  interested in implementing an emerging technology into their products regulated by CDER. 
428  CBERs Advanced Technologies Program promotes dialogue, education, and input between 
429  CBER and prospective developers of advanced manufacturing and testing technologies. The 
430  CATT facilitates such communications to promote the implementation of these technologies in 
431  the development of products regulated by CBER.28  
432   
433  As discussed earlier, engaging with the ETT or CATT is highly encouraged before requesting 
434  AMT designation. FDA recommends not requesting AMT designation at the same time as 
 
27 See 21 CFR 601.2 and draft guidance for industry Drug Master Files (October 2019). When final, this guidance 
will represent the FDAs current thinking on this topic. 
28 For more information about CDERs Emerging Technology Program, see guidance for industry Advancement of 
Emerging Technology Applications for Pharmaceutical Innovation and Modernization (September 2017) and 
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program. For more 
information about CBERs Advanced Technologies Program, see https://www.fda.gov/vaccines-blood-
biologics/industry-biologics/cber-advanced-technologies-program. 
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435  ETT/CATT engagement because ETT and CATT discussions generally occur earlier in the drug 
436  development process and are intended for less mature methods and technologies compared to 
437  AMT designation, which is intended for more mature methods and technologies (e.g., for which 
438  model drug-specific data are available). 
439   
440  In some cases, a particular technology that is not accepted into CDERs Emerging Technology 
441  Program or CBERs Advanced Technologies Program could nevertheless be eligible for AMT 
442  designation. For example, a method of manufacturing could already be at a stage where it is 
443  ready for commercial-scale production. The opposite could also be the case. For example, as 
444  noted in section III, it is possible that the data and information necessary for AMT designation 
445  might not yet be available for a technology granted acceptance into CDERs Emerging 
446  Technology Program or CBERs Advanced Technologies Program. 
447   
448  There are several differences between the three programs. For example, CDERs Emerging 
449  Technology Program and CBERs Advanced Technologies Program can involve activities 
450  outside the scope of AMT designation, such as training of FDA staff. AMT designation requests 
451  are also limited to manufacturing methods, whereas discussions with external stakeholders 
452  through ETT and CATT can involve other elements, such as novel dosage forms or drug delivery 
453  systems. 
454   
455  As discussed elsewhere in this guidance, a requestor or designated AMT holder may not 
456  necessarily be the same entity as the applicant who ultimately uses a designated AMT in an 
457  application. Although a participant in CDERs Emerging Technology Program can also engage 
458  with the ETT without a specific product in development yet, the Emerging Technology Program 
459  is primarily designed for companies that intend to eventually incorporate an emerging 
460  technology into the CMC section of their application. For CBERs Advanced Technologies 
461  Program, the CATT is limited to early engagement before regulatory submission. Therefore, any 
462  meetings regarding the use of a designated AMT that take place after application submission 
463  would generally occur through the Advanced Manufacturing Technologies Designation Program.  
464   
465  Q6.  How does the Advanced Manufacturing Technologies Designation Program differ 
466  from the Platform Technology Designation Program?  
467   
468  Both the Advanced Manufacturing Technologies Designation Program and the Platform 
469  Technology Designation Program29 aim to increase the efficiency of drug development and 
470  manufacturing. However, the two programs generally serve different purposes and apply to 
471  different types of technologies.  
472   
473  Regarding program purpose, one of the distinguishing criteria for a method of manufacturing or 
474  combination of methods being proposed for AMT designation is that it must incorporate a novel 
475  technology or an established technique or technology used in a novel way.30 In contrast, one of 
476  the distinguishing criteria of a designated platform technology is that it is a well-understood and 
 
29 See section 506K of the FD&C Act (21 U.S.C. 356k), added by section 2503 of the Prepare for and Respond to 
Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act of 2022).  
30 See section 505L(b) of the FD&C Act. 
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Draft  Not for Implementation 
477  reproducible technology that is incorporated in or utilized by an approved drug or licensed 
478  biological product.31 For this reason, FDA expects to have previous assessment or inspectional 
479  experience with a designated platform technology. 
480   
481  Regarding eligible methods of manufacturing, a designated AMT is limited to a method or 
482  combination of methods of manufacturing a drug. In contrast, a broader range of technologies 
483  (e.g., nucleic acid sequences, molecular structures, mechanisms of action, delivery methods) is 
484  eligible for platform technology designation, and applicants must demonstrate, among other 
485  criteria,32 that the platform technology is incorporated in or utilized by a drug and is essential to 
486  the structure or function of such drug to receive designation.33 
487   
488  Because of these differences between the two programs, FDA strongly recommends requesting 
489  only the designation that is appropriate for the particular method or technology in question. 
490  There should be no expectation that requesting both designations simultaneously would offer 
491  additional benefits. 
492   
493  Q7.  How should an applicant request engagement with FDA regarding the use of a 
494  designated AMT?  
495   
496  Applicants can request a meeting with FDA to have a preliminary discussion about using a 
497  designated AMT and request subsequent meetings throughout the drug development process. As 
498  described in section IV of this guidance, such meeting requests will typically occur under the 
499  appropriate user fee meeting type and should be made in accordance with the electronic 
500  submission guidance34 and other guidances related to formal meetings between FDA and 
501  applicants.35 Although applicants can request such a meeting at any milestone during the 
502  application assessment process, FDA encourages earlier engagement to enable prompt resolution 
503  of regulatory challenges and more efficient application assessment. Any such submissions should 
504  be clearly identified as a REQUEST FOR A MEETING UNDER THE ADVANCED 
505  MANUFACTURING TECHNOLOGIES DESIGNATION PROGRAM in bold, uppercase 
506  letters. In addition to the content recommended in relevant guidances,36 the meeting background 
507  package should include the timing for application submission and a summary of how the 
508  designated AMT will be used to manufacture the drug. 
 
31 See section 506K(b)(1) of the FD&C Act. 
32 See section 506K(h)(1) of the FD&C Act. 
33 See section 506K(h)(1)(A) of the FD&C Act. 
34 See guidance for industry Providing Regulatory Submissions in Electronic FormatCertain Human 
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (February 2020). 
35 See footnote 21. 
36 Ibid. 
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