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Oct 14 -- The Food and Drug Administration (FDA or Agency) is announcing publication of a discussion paper providing information for stakeholders and soliciting public comments on specific areas of emerging and advanced manufacturing technologies. The discussion paper presents areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing for drugs, including biological products regulated by CDER and the Center for Biologics Evaluation and Research (CBER). FDA recognizes that regulatory policies and programs may need to evolve to enable the timely adoption of these technologies. The discussion paper includes a series of questions for each technology to stimulate feedback from the public. Either electronic or written comments and information on the discussion paper must be submitted by December 13, 2022.

Advanced manufacturing is a general term for an innovative pharmaceutical manufacturing technology or approach that has the potential to improve the reliability and robustness of the manufacturing process and supply chain, and increase timely access to quality medicines for the American public. For the purposes of the discussion paper, all references to drugs include both human drugs and biological products (including those regulated by CBER), unless otherwise specified. Advanced manufacturing can: (1) integrate novel technological approaches, (2) use established techniques in an innovative way, or (3) apply production methods in a new domain. Advanced manufacturing can potentially be used for new or existing and large or small molecule drugs.

FDA has recognized and embraced the potential of advanced manufacturing for many years. CDER established the Emerging Technology Program in 2014 to work collaboratively with companies to support the use of advanced manufacturing. CDER has observed a rapid emergence of advanced manufacturing technologies through the Emerging Technology Program and recognizes that regulatory policies and programs may need to evolve to enable the timely adoption of these technologies. The National Academies of Sciences, Engineering, and Medicine issued a 2021 report entitled “Innovation in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations”, noting potential innovations in integrated, flexible, and distributed manufacturing. These potential innovations include modular approaches to streamline drug development and production, and the deployment and use of highly portable manufacturing units. A range of drug manufacturers have recently engaged CDER through the Emerging Technology Program specifically regarding the development of portable and distributed manufacturing platforms.

CBER established the CBER Advanced Technologies Team in 2019 to promote dialogue, education, and input between CBER and prospective innovators and developers of advanced manufacturing technologies. Through these interactions, CBER has observed interest from manufacturers in the implementation of novel manufacturing approaches for CBER-regulated products. CBER also recognizes the need to consider developing a regulatory framework to facilitate the adoption of these emerging technologies. CBER expects the development of advanced manufacturing technologies associated with DM and POC manufacturing for products that it regulates.

The discussion paper presents areas for consideration and policy development identified by CDER scientific and policy experts associated with DM and POC manufacturing that would be valuable as FDA considers developing a regulatory framework that contemplates these technologies for CDER- and CBER-regulated drug and biological products. For the purposes of the discussion paper, CDER and CBER define DM to be a decentralized manufacturing strategy consisting of a manufacturing platform of manufacturing units deployed to multiple locations; POC manufacturing is defined as a subset of DM that uses manufacturing units distributed to host sites in proximity to patient care (e.g., healthcare facilities). Regulatory areas of consideration include applicable statutory provisions, regulations, and guidance related to quality assessment and inspections that could affect an applicant's ability to comply with the current regulatory framework or FDA's assessment of a marketing application.
The discussion paper is available at:
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cders-framework-regulatory-advanced-manufacturing-evaluation-frame-initiative To facilitate input, FDA has developed a series of questions after each technology described in the discussion paper. The questions are not meant to be exhaustive, and FDA is also interested in any other pertinent information stakeholders would like to share on this topic.

FRN: https://www.federalregister.gov/d/2022-22386

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