Emerging Technology Draft Guidance

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In late December, FDA released for comment an eight-page draft guidance titled “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.”  In the draft, FDA invites companies to participate in a program involving the submission of CMC information containing emerging manufacturing technology to FDA – specifically, those with “elements subject to quality assessment for which the agency 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.” The program is open to companies that intend the technology to be included as part of an investigational new drug application (IND) or original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) reviewed by the Center for Drug Evaluation and Research (CDER). The agency notes that “while the implementation of emerging technology is critical to modernizing pharmaceutical manufacturing and improving quality, FDA also recognizes that innovative approaches to manufacturing 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 approaches. Through [this program], the agency intends to encourage the adoption of innovative approaches to pharmaceutical manufacturing.”  Comments are due by February 22.
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