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# Stakeholders Want More Emerging Technology Info
- URL: https://www.fdaweb.com/stakeholders-want-more-emerging-technology-info/
- Published: 2016-02-24T12:00:00.000Z
- Updated: 2026-09-15T02:38:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134877

> Stakeholders responding to an FDA draft guidance on advancement of emerging technology applications to modernize the pharmaceutical manufacturing base are asking the agency for additional information and clarification. Pharmaceutical Research and Manufacturers of America (PhRMA) [says](http://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2015-D-4644-0008) FDA should clarify the scope and extent of the technologies covered, acceptance criteria for admittance to the program, level of detail required in the application, the anticipated and potential benefits of program participation, and coordination timeframes within the agency to provide program participants with consistent and timely feedback.  
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> “Industry sponsors are investing in and adopting emerging technologies because they offer many business advantages in addition to significant advantages in product quality and process controllability,” the comment letter says. “While PhRMA agrees with FDA on the significance of innovation in manufacturing/CMC technologies and values the collaboration opportunity that participation in the emerging technology team program would provide, PhRMA hopes and expects that the agency will provide consistent guidance on regulatory submissions, while also ensuring a timely and efficient regulatory review process in the spirit of promoting innovation.”  
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> GlaxoSmithKline [says](http://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2015-D-4644-0003) more definition from FDA on what constitutes an “emerging technology” would be helpful, along with a better distinction of whether the agency is proposing a program or a process. And, the letter says, it is not clear whether the process described in the draft guidance has to be followed whenever new technology is being incorporated, or whether that route is an option.  
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> The Generic Pharmaceutical Association (GPhA) [says](http://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2015-D-4644-0007) it believes that evaluation of emerging technologies represents an opportunity to modernize manufacturing operations as well as optimize strategies to help assure product quality. “GPhA believes that a significant factor in promoting new technologies will be for global regulatory agencies to harmonize on the regulatory expectations for adoption and implementation of emerging technologies,” the letter says. “GPhA believes that a discussion with industry on the potential adoption of new technologies is valuable. Because various technologies are at different stages of development, the risk-benefit implementation of these technologies, net value to product quality, among others are important considerations that will merit ongoing stakeholder discussion.”  
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> Finally, Baxter [asks](http://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2015-D-4644-0005) for a better definition of “emerging technology,” saying that ideally it would include not only manufacturing technology such as equipment design and processing techniques, but also innovative approaches to development, validation, novel sterilization, data management, quality control, quality management, etc., which also have the potential to modernize pharmaceutical manufacturing. And the company asks FDA to provide more examples of “emerging technologies.”  
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