This past December, the FDA released a draft guidance addressing a growing problem facing pharmaceuticals today: innovation.
Emerging technologies have made it possible for drug manufacturers to remedy a variety of problems that plagued operations in the past. Advanced automation equipment, for example, has led to less operator error while isolators and other separation technologies have lessened contamination on the processing line.
But as the FDA notes in the new draft guidance, the Agency’s inability to keep up with many of these emerging technologies has made pharmaceuticals hesitant to use them despite the obvious benefits.
“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 approaches.”
To make up for the FDA’s “limited knowledge and experiential base” for new technologies, the Agency is launching a new program—The Emerging Technology Team (ETT)—aimed at providing early engagement and additional meeting opportunities for companies interested in implementing emerging manufacturing technologies into their production process.
What is the Emerging Technology Team (ETT)?
The ETT is a new group within the Center for Drug Evaluation and Research (CDER) which work as partners with quality offices to lead the cross-functional quality assessment team for submissions involving emerging technology.
How can the ETT help?
As the primary point of contact for companies interested in implementing emerging manufacturing technology and relevant quality assessment team, the ETT can:
- Answer an applicant/sponsor’s questions about the information FDA expects to see in their submission;
- Identify and help facilitate regulatory review of a new manufacturing technology in accordance with existing legal and regulatory standards, guidance, and Agency policy related to quality assessment;
- Serve as the lead or co-lead on the quality assessment team, in partnership with relevant CDER pharmaceutical quality offices, to review and make the final quality recommendation regarding the potential approval of submissions in the program; and
- Identify and capture resolution to policy issues that may inform FDA approaches and recommendations regarding future submissions that involve the same technology.
The FDA intends to work with participants on a one-to-one level, including appropriate coordination with FDA staff involved in the review of CMC sections of the application and facility evaluation.
Can this program actually help ensure quality submissions?
The FDA makes it clear in the draft guidance that quality “cannot be tested into products.” Rather, it should be built-in or present by design. As they put it, quality is built into pharmaceutical products through a “comprehensive understanding” of
the product’s:
- • Formulation
- • Analytical Methods
- • Design of facility
- • Manufacturing processes and equipment
Given this rationale, this program could encourage companies to adopt emerging technologies faster than they otherwise would by getting easier access to resources within the FDA that deal directly with submissions involving emerging technologies.
Who can participate in the ETT program?
Acceptance to the program depends on applicants’ proposed plans for submission of an IND or original or supplemental ANDA, BLA, or NDA based on a few key criteria.
The submission should include one or more quality assessment elements for which the FDA has limited review or inspection experience, where the technology “has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable, or cost-effective processes.” This includes:
- • Innovative product manufacturing technology (like dosage form)
- • Innovative manufacturing process (design, scale-up, and/or commercial scale)
- • Innovative testing technology
The program only affects the quality section of the submission (CMC and facility-related information). Existing requirements related to the review and 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.
How can I participate?
According to the draft guidance, interested parties should submit a written request for a Type C meeting as described here.
The request should be specified as a “Type C meeting – request to participate in the ETT 137 program.”
Similarly, those planning to submit an ANDA should submit a pre-ANDA meeting request and specify it as a “Pre-ANDA meeting – request to participate in the 139 ETT program.”
Either way, the request should be submitted at least three months before the planned application submission date.
See the draft guidance for a list of key elements to include in your request and what to expect following submission.
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