About FDA

Emerging Technology Program

Background

test tubesCDER’s Office of Pharmaceutical Quality created the Emerging Technology Program (FDA Voice on Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs) to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing. The program leverages existing resources within the Agency to facilitate the regulatory quality assessment (including both review and inspection) of submissions to the Agency involving novel technologies likely to improve product safety, identity, strength, quality, and purity. The program features the Emerging Technology Team (ETT), which includes representation from all FDA pharmaceutical quality functions, to provide cross-functional expertise to the questions posed by program participants on their proposed technology.

About the Emerging Technology Program

Transcript

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. Through the program, industry representatives can meet with ETT members to discuss, identify, and resolve potential concerns regarding the development and implementation of a novel technology prior to filing a regulatory submission.

The ETT is intended to encourage technology for use in product design and pharmaceutical manufacturing; thus, acceptance of a request to participate will depend on the applicant’s proposed plan for a regulatory submission including investigational new drug application (IND), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA) or biologic license application (BLA), or application-associated Drug Master File (DMF)  reviewed by the Center for Drug Evaluation and Research (CDER), based on the criteria described in the FDA Emerging Technology Guidance.  This program only affects the quality section of applications to FDA (CMC and facility-related information).

What Does Industry Gain from Participating in Emerging Technology Program? 

Participants in the Emerging Technology Program gain the following benefits:

  • Potential early face-to-face meetings to discuss the intersection of technical and regulatory challenges related to adopting a proposed technology during the technology development (even before the lead drug molecule is identified)
  • Opportunity for continued interactions with FDA staff (including ETT members) with relevant experience to gain their feedback on the proposed technology and facilitate the regulatory submission preparation

Emerging Technology in the News

Since its inception, ETT has had a number of successful partnerships with industry sponsors.

Emerging Technology and the ETT in Peer-Reviewed Publications

Continuous Manufacturing

Additive Manufacturing

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 close loop bioreactor control
    • Multi-attribute method
    • Next generation sequencing
    • Continuous manufacturing for a upstream process
    • 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

Is Emerging Technology Program Right for your Company?

Biotechnology LabApplications to the ETT are 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 ETT Program?

Interested parties 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 following the directions outlined in the Emerging Technology Guidance. The request should generally not exceed five pages of narrative. The meeting request and related questions should be submitted electronically to CDER-ETT@fda.hhs.gov.

Related Agency Information

 

Page Last Updated: 09/22/2017
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