Advancement of 
Emerging Technology 
Applications for 
Pharmaceutical 
Innovation and  
Modernization 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
September 2017 
Pharmaceutical Quality/CMC 
2483881 FNL 
  Contains Nonbinding Recommendations 
 
Advancement of 
Emerging Technology 
Applications for 
Pharmaceutical 
Innovation and 
Modernization  
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  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
  
September 2017 
Pharmaceutical Quality/CMC 
   
i 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  DISCUSSION .................................................................................................................... 3 
A.  Scope ............................................................................................................................................... 4 
B.  Process ............................................................................................................................................. 4 
ii 
  Contains Nonbinding Recommendations 
 
Advancement of Emerging Technology Applications for 
Pharmaceutical Innovation and Modernization  
1
Guidance for Industry  
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.  
 
 
 
I.  INTRODUCTION  
 
This guidance provides recommendations to pharmaceutical companies interested in 
participating in a program involving the submission of chemistry, manufacturing, and controls 
(CMC) information containing emerging technology2 to FDA. The program is open to 
companies that intend to include the technology as part of a regulatory submission including 
investigational new drug applications (IND), original or supplemental new drug applications 
(NDA), abbreviated new drug applications (ANDA) or biologic license applications (BLA), or 
application-associated Drug Master Files (DMF)3 reviewed by the Center for Drug Evaluation 
and Research (CDER), and where that technology meets other criteria described in this guidance. 
This program does not cover products reviewed by the Center for Biologics Evaluation and 
Research.  
 
Issues in pharmaceutical manufacturing have the potential to significantly impact patient care as 
failures in quality may result in product recalls and harm to patients. Additionally, product 
failures or facility, equipment, or manufacturing problems are a major factor leading to 
disruptions in drug supply. Modernizing manufacturing4 technology may lead to a more robust 
manufacturing process with fewer interruptions in production, fewer product failures (before or 
after distribution), and greater assurance that the drug products manufactured in any given period 
of time will provide the expected clinical performance. For example, contemporary aseptic 
                                                 
1 This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and 
Research at the Food and Drug Administration. 
2 For the purpose of this document, emerging technology should be novel in the context of the pharmaceutical and 
related industries and it should have the potential to modernize the pharmaceutical manufacturing body of 
knowledge related to product quality. Emerging technology will be new to FDA in the context of pharmaceutical 
quality, with limited prior experience and knowledge. 
3 This program is also open to companies or manufacturers that intend to include emerging technology in a drug 
master file (DMF) that will be referenced by the planned application(s). The steps to request participation in the 
program are described in section III.B Process.  
4 For the purpose of this guidance, the definition of manufacturing includes testing, packaging and labeling 
operations, and quality control across the product lifecycle (e.g., design, qualification, and commercial 
manufacturing). Refer to 21 CFR 210.3(b)(12).  
  1  Contains Nonbinding Recommendations 
 
manufacturing facilities that are highly automated and use isolators and other modern separation 
technologies have the potential to decrease the risk of contamination from the processing line. 
Encouraging development of emerging technology may lead to pharmaceutical innovation and 
modernization, such as a more robust drug product design and improved manufacturing with 
better process control, thereby leading to improved product quality and availability throughout a 
products lifecycle. 
 
In this program, pharmaceutical companies can, prior to the regulatory submission, submit 
questions and proposals about the use of specific emerging technology to a group within FDA 
(Emerging Technology Team  ETT), which includes relevant representation from all FDA 
pharmaceutical quality functions. The ETT works in partnership with relevant pharmaceutical 
quality offices and assumes a leadership or co-leadership role for the cross-functional quality 
assessment team (including review and on-site facility evaluation or inspection) for submissions 
involving emerging technology. The ETT serves as the primary point of contact for companies 
that are interested in implementing emerging technology in the manufacture of their drug 
products and for the relevant quality assessment team to:  
 
(a) Answer sponsor/applicant questions about the information FDA expects to see in 
their submission;  
 
(b) Identify and help facilitate regulatory assessment of an emerging technology in 
accordance with existing legal and regulatory standards, guidance, and Agency policy 
related to quality assessment; 
 
(c) Serve as the lead or co-lead on the quality assessment team (i.e., staff involved in the 
review of the CMC sections of the application and evaluation of the manufacturing 
facilities), in partnership with relevant pharmaceutical quality offices, including the 
Office of Compliance and Office of Regulatory Affairs, as appropriate, to conduct 
review, on-site evaluation, and make the final quality recommendation regarding the 
potential approval of submissions in the program; and 
 
(d) Identify and resolve policy issues to inform FDA approaches and recommendations 
regarding future submissions that involve the same technology.  
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.   
 
II.  BACKGROUND 
 
FDA is committed to supporting and enabling pharmaceutical innovation and modernization as 
part of the Agencys mission to protect and promote the public health. The Agency hopes that 
  2  Contains Nonbinding Recommendations 
 
these efforts may also help reduce the number of drug shortages, as noted in FDAs drug 
shortage strategic plan.5 In 2002, FDA launched an initiative entitled Pharmaceutical cGMPs 
for the 21st Century: A Risk-Based Approach, to encourage the implementation of a modern, 
risk-based pharmaceutical quality assessment system.6 One of the goals of this initiative was to 
encourage the early adoption of new technological advances by the pharmaceutical industry and 
ensure that regulatory review, compliance, and inspection policies are based on state-of-the-art 
pharmaceutical science. In 2004, this was further described in the FDA guidance for industry 
entitled PATA Framework for Innovative Pharmaceutical Development, Manufacturing, and 
Quality Assurance.7 This guidance describes a scientific, risk-based framework intended to 
support innovation and efficiency in pharmaceutical development, manufacturing, and quality 
assurance. The guidance also describes the concept that quality cannot be tested into products; in 
other words, it should be built in or should be present by design. Quality is built into 
pharmaceutical products through a comprehensive understanding of the intended use of the 
product, the characteristics of the product, and the design of the product and manufacturing 
process using principles of engineering, material science, and quality assurance to ensure 
acceptable and reproducible product quality and performance throughout a products lifecycle. 
  
FDA continues to support flexible approaches in the manufacturing of quality pharmaceutical 
products. While the implementation of emerging technology is critical to advancing product 
design, modernizing pharmaceutical manufacturing, and improving quality, FDA also recognizes 
that the adoption of innovative approaches may represent challenges to industry and the Agency. 
By the very nature of an approach being innovative, a limited knowledge and experiential base 
about the technology may exist. Pharmaceutical companies may have concerns that using such 
technologies could result in delays while FDA reviewers familiarize themselves with the new 
technologies and determine how they fit within existing regulatory framework. Through the 
Emerging Technology Program, FDA intends to encourage the adoption of innovative 
approaches to product design and pharmaceutical manufacturing by leveraging existing resources 
within the Agency to facilitate the regulatory assessment of submissions to the Agency involving 
novel technologies likely to improve product quality and availability throughout a products 
lifecycle.  
 
III.  DISCUSSION   
 
As part of this program, FDA intends to provide early engagement and additional meeting 
opportunities, which enable the participants and FDA to discuss: (1) product or manufacturing 
design and development issues, and (2) submission content related to the emerging technology. 
The process will include appropriate coordination with the FDA quality assessment team. Based 
on experience gained during the program, FDA intends to develop guidance and standards, as 
                                                 
5 See FDAs Strategic Plan for Preventing and Mitigating Drug Shortages at: 
https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf.  
6 See Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach at: 
https://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/questionsandanswersoncurrentg
oodmanufacturingpracticescgmpfordrugs/ucm176374.pdf. 
7 We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA 
Drugs guidance Web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
  3  Contains Nonbinding Recommendations 
 
necessary, on emerging technologies and approaches to encourage and facilitate the innovation 
and modernization in pharmaceutical industry. 
 
A.  Scope  
 
Acceptance of a request to participate in this program will depend on the applicants proposed 
plan for submission of an IND, original or supplemental ANDA, BLA, or NDA, or application-
associated DMF based on the criteria described below.   
 
  The planned submission should include one or more elements which will be subject to 
quality assessment for which the Agency has limited review or inspection 
experience. Examples of such elements include an innovative or novel: (1) product 
technology (e.g., dosage form or container-closure system); (2) manufacturing process 
(e.g., design, scale-up, or lifecycle approaches); and/or (3) control strategy (e.g., testing 
technology or process controls).   
 
  The proposed technology in the planned submission has the potential to improve product 
safety, identity, strength, quality, or purity (e.g., an innovative process design that can 
lead to a more robust and predictable production of quality pharmaceutical products).   
 
In the request to the Agency, the applicant should provide sufficient justification that the 
proposed emerging technology in the planned submission meets the above criteria (see section 
III.B Process for details regarding steps to request participation in the program). Such an 
approach, rather than providing a prescriptive set of acceptance criteria, enables the program to 
be open to a wide variety of novel manufacturing technologies. As a reminder, this program only 
affects the quality section of the submission (CMC and facility-related information). Existing 
requirements related to the review and determination of adequacy or approval of a submission 
will not be waived, suspended, or modified for purposes of this program. Applicants must make 
the submission in accordance with 21 CFR parts 312, 314, 601, and other applicable standards. 
 
B.  Process 
 
Parties planning to submit an IND, original or supplemental BLA or NDA, or application-
associated DMF, and who have an interest in participating in this FDA program should submit a 
written request for a Type C meeting as described in the FDA guidance for industry Formal 
Meetings Between the FDA and Sponsors or Applicant. The request should specify the meeting 
request as a Type C meeting  request to participate in the Emerging Technology Program. 
Interested parties planning to submit an ANDA should submit a pre-ANDA meeting request and 
specify the meeting request as a Pre-ANDA meeting  request to participate in the Emerging 
Technology Program. Either type of request should be submitted at least three months prior to 
the planned application submission date. The meeting request and related questions should be 
submitted electronically to CDER-ETT@fda.hhs.gov.8 In addition to the items outlined in the 
                                                 
8 If the request includes commercial confidential information, it is the responsibility of the company to ensure it is 
one of FDAs secure messaging partners. Companies may request to be added to the list of FDAs secure messaging 
partners by sending a request to: SecureEmail@fda.hhs.gov. 
  4  Contains Nonbinding Recommendations 
 
referenced guidance, the request should also include the following items and should not exceed 
five pages including figures and tables:  
 
(1) A brief description of the proposed emerging technology;  
 
(2) A brief explanation why the proposed emerging technology is substantially novel and 
unique and should be considered under this program; 
 
(3) A description of how the proposed emerging technology could potentially improve 
product safety, identity, strength, quality, or purity;  
 
(4) A summary of the development plan and any perceived roadblocks to implementation 
(e.g., technical or regulatory); and 
 
(5) A timeline for a submission of an IND, original or supplemental ANDA, BLA, or NDA, 
or DMF and its associated application.  
 
Based on the availability of Agency resources, we expect to limit acceptance into the program to 
technologies that are likely to advance product design or modernize pharmaceutical 
manufacturing, and with which the Agency has limited prior experience and knowledge. FDA 
expects to notify companies of its decision regarding acceptance into the program in writing 
within 60 days of receipt of the request. Although incomplete and/or unclear requests will 
generally be denied, FDA may contact the applicant to request additional information. Once 
accepted into the program, the participant can engage with the ETT and quality assessment team 
in accordance with existing meeting procedures and guidance(s).9   
                                                 
9 See the FDA guidances for industry on Formal Meetings Between the FDA and Sponsors or Applicants (see 
information on Type C meetings) and Controlled Correspondence Related to Generic Drug Development. 
  5