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6 - The regulated market: gateway through the FDA

Published online by Cambridge University Press:  03 November 2022

Shreefal S. Mehta
Shreefal S. Mehta
Affiliation:
The Paper Battery Company
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Summary

From the long path through preclinical development, entering the regulatory field of interactions for human clinical trials can sometimes feel like you are walking into the lion’s den. This chapter guides you through an understanding of how to interact and how to prepare for FDA meetings so that they are on your side rather than fighting you. The common goals of companies and the FDA are highlighted here. Specific issues with identifying the appropriate regulatory approval pathway are discussed here with cautionary case studies. Complex new technologies which combine diagnostics and drugs, or devices and software, or AI-based dynamic software are reviewed here. The best approach to the appropriate regulatory pathway will be clear after reading this chapter. Case studies are used to show successful pathways taken by cutting-edge developments, such as cell-based therapy.

Keywords

FDAEMAJapanChinaIndiaregulatoryharmonizationclassificationclass IIClass IClass IIIPMA510(k)510k505b2505(b)2,INDBLEIDENDADMFmaster fileANDAgeneric505(b)(2)clinical trialsmeeting with FDApre-IND meetingClass C meetingOTC drugsdrugpharmaceuticalmedical devicemedtechdiagnosticsmolecular diagnosticshatch waxmanorange booksafetysurveillanceorphan drugEuropean UnionEUQualityQSRQMScontrolsmaster fileCE markHumanitarian useIVDCLIAClinical labASRAnalytereagentsLDTLaboratory derived testhome brewpharmacogeneticcompanion diagnosticcombinationartificial intelligencemachine learningAIMLSaMDsoftware medical devicegene therapytissue therapycell therapyregenerative,
Type
Chapter
Information
Commercializing Successful Biomedical Technologies , pp. 239 - 308
Publisher: Cambridge University Press
Print publication year: 2022

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References

References and additional readings

Amato, SF, and Ezzell, RM Jr. (editors). (2014). Regulatory Affairs for Biomaterials and Medical Devices. Elsevier Science and Technology. ISBN: 9780081015339Google Scholar
Beck, JM, and Vale, A. (2004). Drug and Medical Device Product Liability Deskbook. New York: Law Journal Press. ISBN: 1-58852-121-4Google Scholar
Benjamens, S, Dhunnoo, P, and Meskó, B. (2020). The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database. npj Digital Medicine 3, 118.Google Scholar
Cauchon, NS, Oghamian, S, Hassanpour, S, and Abernathy, M. (2019). Innovation in chemistry, manufacturing, and controls – a regulatory perspective from industry. Journal of Pharmaceutical Sciences – Review 108(7), p2207–2237.Google Scholar
Daniel, A., and Kimmelman, E. (Compilers) (2008). The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices. ASQ Quality Press. ISBN: 9780873897402Google Scholar
Flannery, EJ, and Danzis, SD. (2010). In Vitro Diagnostics: The Complete Regulatory Guide. Food and Drug Law Institute. ISBN: 9781935065227Google Scholar
Harnack, G. Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration, 2nd ed. New York: ASQ Quality Press. ISBN: 9780873898874Google Scholar
Pines, WL, and Kanovsky, SM. (editors). (2020). A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th ed. Published by Food and Drug Law Institute. ISBN: 9781935065876Google Scholar
Pisano, D., David Mantus, D. (editors). (2004). FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics. New York: CRC Press. ISBN: 1-58716-007-2Google Scholar
Royzman, I, and Shah, K. (2020). 10 years of biosimilars: lessons and trends. Nature Reviews Drug Discovery 19, 375.Google Scholar
Salminen, WF, Wiles, ME, and Stevens, RE. (2019). Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway. Drug Discovery Today 24(1), 46–56.Google Scholar
Seimetz, D, Heller, K, and Richter, J. (2019). Approval of first CAR-Ts: have we solved all hurdles for ATMPs? Cell Medicine 11.Google Scholar
Tobin, JT, Walsh, G. (2021). Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices. Wiley-VCH Verlag GmbH. ISBN: 9783527333264Google Scholar
Van Norman, GA. (2016). Drugs and devices: comparison of European and U.S. approval processes. JACC: Basic to Translational Science 1(5), 399–412.Google Scholar

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