About the Emerging Technology Program

FDA recognizes that adopting innovative approaches to manufacturing may present both technical and regulatory challenges. 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 may be evaluated within the existing regulatory framework. To address these concerns, CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing. Through the program, industry representatives can meet with Emerging Technology Team (ETT) members to discuss, identify, and resolve potential technical and regulatory issues regarding the development and implementation of a novel technology prior to filing a regulatory submission.

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What Does Industry Gain from Participating in the Emerging Technology Program?

Participants in the Emerging Technology Program gain the following benefits:

• Pre-submission face-to-face interactions with ETT members and review staff to answer technical and regulatory questions during the development and adoption of the proposed technology
• Opportunity for early interactions with the ETT and review staff on the proposed technology to gather feedback in preparation for a regulatory submission

Is the Emerging Technology Program Right for your Company?

Participation in the program is appropriate if (a) the proposed technology has the potential to improve product safety, identity, strength, quality and purity, and (b) the new technology includes one or more elements 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 packaging such as a container and 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).

How Does a Company Join the Emerging Technology Program?

Industry representatives planning to submit an IND, original or supplemental NDA, ANDA or BLA, or application-associated DMF as part of this CDER program should submit a written request to participate in the program and proposal (not to exceed five pages) as outlined in the Emerging Technology Guidance. Requests and proposals should be submitted electronically to [email protected]. Note: This program only affects the quality section of applications to FDA (CMC and facility-related information).

Examples of Emerging Technologies Considered by ETT

• Emerging technologies for small molecules
  • Continuous manufacturing of drug substance
  • Continuous manufacturing of drug product
  • Model-based control strategy for continuous manufacturing
  • Continuous aseptic spray drying
  • 3D printing manufacturing
  • Ultra-long-acting oral formulation
• Emerging technologies for biological molecules
  • Controlled ice nucleation for lyophilization processes
  • Advanced process control such as predictive modeling for process monitoring and closed loop bioreactor control
  • Multi-attribute method
  • Next generation sequencing
  • Continuous manufacturing for downstream processes
  • Pharmacy on demand (a small manufacturing platform for continuous bioprocesses)
• Emerging technologies for multiple products
  • Closed aseptic filling system
  • Isolator and robotic arm for aseptic filling
  • Novel container and closure systems for injectable products

Emerging Technology in the News

Since its inception, ETT has engaged in numerous successful partnerships with industry sponsors. Review the links below to learn more about ETT’s impact and presence at the FDA and throughout the industry.

General Information

• February 2019: Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility (FDA Press Announcements)
• December 2018: Microbiology Modernisation Cross-industry Consortium takes shape (Cleanroom Technology)
• August 2018: FDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation (FDA Voice)

Emerging Technology and the ETT in Peer-Reviewed Publications

• September 2015: Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production (J Pharm Innov, doi:10.1007/s12247-015-9215-8)
• July 2016: Emerging Technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality (Intl J Pharm, http://dx.doi.org/10.1016/j.ijpharm.2016.05.058)

Continuous Manufacturing

• September 2019: Continuous Manufacturing and its Regulatory Challenge (ContractPharma)
• August 2019: FDA Calls on Manufacturers to Begin Switch from Batch to Continuous Production (in-PharmaTechnologist)
• February 2019: Statement from FDA Commissioner Scott Gottlieb, M.D., on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs (FDA Press Announcements)
• August 2018: FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development (Imperial Valley News) 
• July 2018: Continuous Process Verification and the Drive to Digitize the Process Validation Lifecycle (BioPharm International)

Additive Manufacturing

• March 2018: 3D  PRINTING - 3D Printed Drugs Hold Great Potential for Personalized Medicine (Drug Development & Delivery)
• December 2017: Statement by FDA commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices (FDA Press Announcements)
• March 2016: FDA Approved 3D Printed Drug Available in the US (Forbes)
• August 2016: FDA and the Emerging Technology of 3D Printing (PharmTech.com)

Digital Health

• April 2019: FDA unveils framework for AI-based medical devices (Med Tech Drive)
• November 2018: FDA Proposes New Framework on Prescription Drug-Related Software (Regulatory Focus)

Related Agency Information

• Office of Pharmaceutical Quality
• Center for Drug Evaluation and Research
• Breakthrough Therapy
• CDRH Innovation
• CDER Small Business & Industry Assistance (SBIA)
• FDA Advancing Regulatory Science
• FDA Meeting Types (PDF - 83 KB)