A study on the US FDA Regulatory requirements for Stem Cell Based-Products
Abstract
Purpose: To thoroughly investigate the regulatory structure implemented by the U.S. Food and Drug Administration (FDA) for products derived from stem cells. As regenerative medicine advances, it is essential to comprehend the FDA's function in safeguarding the safety, effectiveness, and quality of these therapies.
This research utilizes a thorough method to explore the regulatory requirements set by the U.S. Food and Drug Administration (FDA) for stem cell-derived products. The approach combines qualitative analysis, document review, and case study assessment to evaluate the FDA's regulatory structure and its influence on the advancement and authorization of regenerative treatments.
Results and discussion: This research examine the U.S. FDA's regulatory framework for stem cell-derived products, including combination products. It clarifies the distinctions between Section 361 and Section 351 HCT/Ps based on criteria like minimal manipulation and homologous use. The article discusses various regulatory pathways, emphasizing the need for Investigational New Drug (IND) and Biologics License Applications (BLA). Additionally, it explores the regulation of stem cell combination products, which may involve devices or drugs. The FDA's strategy for regulating stem cell-based products demonstrates a dedication to finding a balance between innovation and patient protection. Although important advancements have been achieved in creating explicit guidelines and enforcement strategies, persistent challenges in product characterization, manufacturing processes, and international cooperation need ongoing focus.
Keywords:
Combination Products, Stem Cell-Based Products, HCT/P, CBER, OCP, IND, BLA, Public Health Service
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References
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21. European Medicines Agency. Draft guideline on similar biological medicinal products containing monoclonal antibodies [Internet]. London: EMA; 2010 [cited 2024 Jun 29].
22. [Author unknown]. BLA versus NDA [Internet]. [cited 2025 Feb 21]. Available from: http://www.slideshare.net/gas25/usfda-nda-vs-bla
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35. Reddy NM. Regulatory requirements for the registration of biologics in the U.S. Int J Pharma Chem Res. 2018;4(3):219–28.
36. U.S. Food and Drug Administration. ALLOCORD (HPC, Cord Blood) Prescribing Information [Internet]. St. Louis (MO): FDA; 2013 [cited 2025 Apr 24]. Available from: https://www.fda.gov/media/86181/download
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45. U.S. Food and Drug Administration. KYMRIAH (Tisagenlecleucel) Prescribing Information [Internet]. East Hanover (NJ): FDA; 2017 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/107296/download
46. US Food and Drug Administration. YESCARTA® (axicabtagene ciloleucel) prescribing information. Santa Monica, CA: USFDA; 2017 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/108377/download
47. US Food and Drug Administration. TECARTUS™ (brexucabtagene autoleucel) prescribing information. Santa Monica, CA: USFDA; 2020 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/140409/download
48. US Food and Drug Administration. ABECMA® (idecabtagene vicleucel) prescribing information. Summit, NJ: USFDA; 2021 [cited 2025 Apr 24]. Available from: https://www.fda.gov/media/147055/download
49. US Food and Drug Administration. PROVENGE® (sipuleucel-T) prescribing information. Seattle, WA: USFDA; 2010 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/78511/download
50. US Food and Drug Administration. GINTUIT® (allogeneic cultured keratinocytes and fibroblasts in bovine collagen) prescribing information. Canton, MA: USFDA; 2012 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/83264/download
51. US Food and Drug Administration. LAVIV® (azficel-T) prescribing information. Exton, PA: USFDA; 2011 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/80838/download
52. US Food and Drug Administration. MACI® (autologous cultured chondrocytes on porcine collagen membrane) prescribing information. Cambridge, MA: USFDA; 2016 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/101914/download
53. Hyun I. Allowing innovative stem cell-based therapies outside of clinical trials: ethical and policy challenges. J Law Med Ethics. 2010;38(2):277–85.
54. Dresser R, Frader J. Off-label prescribing: a call for heightened professional and government oversight. J Law Med Ethics. 2009;37(3):476–86.
2. Hildreth C. How does the U.S. FDA regulate cell therapies? (351 vs 361 products) [Internet]. BioInformant; 2018 [cited 2025 Jan 29]. Available from: https://bioinformant.com/351-vs-361-products/
3. U.S. Food and Drug Administration. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use [Internet]. Silver Spring (MD): FDA; 2020 [cited 2025 Jan 29]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal
4. U.S. Food and Drug Administration. Expedited programs for regenerative medicine therapies for serious conditions: guidance for industry [Internet]. Silver Spring (MD): FDA; 2019 Feb [cited 2025 Jan 29]. Available from: https://www.fda.gov/media/120267/download
5. U.S. Food and Drug Administration. Expedited programs for serious conditions – drugs and biologics: guidance for industry [Internet]. Silver Spring (MD): FDA; 2014 May [cited 2025 Jan 29]. Available from: https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf
6. U.S. Food and Drug Administration. Designating an orphan product: drugs and biological products [Internet]. Silver Spring (MD): FDA; 2024 Jun [cited 2025 Jan 29]. Available from: https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products
7. Giuseppe A, Sabrina S, Lo Cicero V, Francesco S, Daniel S, Lucia T, et al. [Title of the article]. Am J Transl Res. 2010;2:285–95.
8. U.S. Food and Drug Administration. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception; guidance for industry [Internet]. Silver Spring (MD): FDA; 2017 Nov [cited 2025 Jan 30]. Available from: https://www.fda.gov/media/89920/download
9. U.S. Food and Drug Administration. Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Final rule. Fed Regist. 2001 Jan 19;66(13):5447–57. Available from: https://www.govinfo.gov/content/pkg/FR-2001-01-19/pdf/01-1126.pdf
10. U.S. Food and Drug Administration. Proposed approach to regulation of cellular and tissue-based products. Fed Regist. 1997 Mar 4;62(42):9721–33. Available from: https://www.fda.gov/media/70704/download
11. U.S. Food and Drug Administration. IND process and review procedures. Manual of policies and procedures. Silver Spring (MD): Center for Drug Evaluation and Research, FDA; [cited 2025 Feb 02]. Available from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM082022.pdf
12. Evens RP, editor. Drug and biological development: from molecule to product and beyond. New York: Springer; 2007.
13. U.S. Food and Drug Administration. Treatment use of investigational drugs: information sheet [Internet]. Rockville (MD): FDA; [cited 2025 Feb 12]. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126495.htm
14. Guarino RA. New drug approval process. 5th ed. New York: Informa Healthcare; 2009. (Drugs and the Pharmaceutical Sciences; vol. 190).
15. U.S. Food and Drug Administration. The Biopharmaceutics Classification System [Internet]. Rockville (MD): FDA; [cited 2025 Feb 17]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070246.pdf
16. U.S. Food and Drug Administration. Drug Price Competition and Patent Term Restoration Act of 1984; 1984 [Internet]. [cited 2025 Feb 20]. Available from: http://www.kenyon.com/Resources/Hatchman/HTMLHelp/!SSL!/WebHelp/Public_Laws/P_L_98_417_1984_htm
17. Medina C, editor. Compliance handbook for pharmaceuticals, medical devices, and biologics [Internet]. Boca Raton (FL): CRC Press; 2004 [cited 2025 Feb 21]. Available from: http://books.google.co.in/books?id=eItrl4IL5VkC
18. Central Drugs Standard Control Organization. Guidelines on similar biologics: regulatory requirements for marketing authorization in India. New Delhi: CDSCO; 2016.
19. U.S. Food and Drug Administration. Review procedure of BLA by the USFDA [Internet]. [cited 2025 Feb 21]. Available from: https://www.law.cornell.edu/cfr/text/21/601.25
20. European Medicines Agency. Guideline on similar biological medicinal products [Internet]. London: EMA; 2005 [cited 2025 Feb 21]. Available from: http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf
21. European Medicines Agency. Draft guideline on similar biological medicinal products containing monoclonal antibodies [Internet]. London: EMA; 2010 [cited 2024 Jun 29].
22. [Author unknown]. BLA versus NDA [Internet]. [cited 2025 Feb 21]. Available from: http://www.slideshare.net/gas25/usfda-nda-vs-bla
23. Allen LV Jr, Ansel HC. Pharmaceutical dosage forms and drug delivery systems. 10th ed. Philadelphia: Wolters Kluwer Health; 2014.
24. U.S. Food and Drug Administration. Guidance for industry: providing regulatory submissions in electronic format—NDAs [Internet]. Silver Spring (MD): FDA; 1999 Jan [cited 2025 Feb 22]. Available from: https://www.fda.gov/media/71129/download
25. U.S. Food and Drug Administration. Investigational New Drug Application (FDA Form 1571) [Internet]. Silver Spring (MD): FDA; [cited 2025 March 02]. Available from: https://www.fda.gov/media/123543/download
26. McCamish M, Woollett G. Worldwide experience with biosimilar development. mAbs. 2011;3(2):209–17.
27. Baldrick P. Safety evaluation of biological drugs: what are toxicology studies in primates telling us? Regul Toxicol Pharmacol. 2011;59(2):227–36.
28. Douthwaite J, Jermutus L. Exploiting directed evolution for the discovery of biologicals. Curr Opin Drug Discov Devel. 2006;9(2):269–75.
29. Lipinski CA, Lombardo F, Dominy BW, Feeney PJ. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv Drug Deliv Rev. 2001;46(1–3):3–26.
30. Federal Register. Washington (DC): U.S. Government Printing Office; [cited 2025 Apr 02]. Available from: http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR
31. U.S. Food and Drug Administration. Biologics License Applications (BLA) Process (CBER) [Internet]. Silver Spring (MD): FDA; [cited 2025 Apr 12]. Available from: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber
32. Troutman Sanders LLP. Biologic License Application (BLA) Checklist [Internet]. [cited 2025 Apr 15]. Available from: https://www.yumpu.com/en/document/read/12370314/biologic-license-application-bla-checklist-troutman-sanders-llp
33. MasterControl. Biologics License Application [Internet]. [cited 2025 Apr 18]. Available from: https://www.mastercontrol.com/regulatory/biologics-license-application/
34. Credevo. Drug Approval Regulatory in the United States – Part II [Internet]. 2020 May 15 [cited 2025 Apr 18]. Available from: https://credevo.com/articles/2020/05/15/drug-approval-regulatory-in-the-united-states-part-ii/
35. Reddy NM. Regulatory requirements for the registration of biologics in the U.S. Int J Pharma Chem Res. 2018;4(3):219–28.
36. U.S. Food and Drug Administration. ALLOCORD (HPC, Cord Blood) Prescribing Information [Internet]. St. Louis (MO): FDA; 2013 [cited 2025 Apr 24]. Available from: https://www.fda.gov/media/86181/download
37. U.S. Food and Drug Administration. CLEVECORD (HPC, Cord Blood) Prescribing Information [Internet]. Cleveland (OH): FDA; 2016 [cited 2025 Apr 26]. Available from: https://www.fda.gov/media/99648/download
38. U.S. Food and Drug Administration. HEMACORD (HPC, Cord Blood) Prescribing Information [Internet]. Long Island City (NY): FDA; 2011 [cited 2025 Apr 26]. Available from: https://hemacord.info/pub/Prescribing%20Information%20and%20Instructions.pdf
39. U.S. Food and Drug Administration. DUCORD (HPC, Cord Blood) Prescribing Information [Internet]. Durham (NC): FDA; 2012 [cited 2025 Apr 26]. Available from: https://www.fda.gov/media/83601/download
40. U.S. Food and Drug Administration. HPC, Cord Blood Prescribing Information [Internet]. Aurora (CO): FDA; 2012 [cited 2025 Apr 26]. Available from: https://www.fda.gov/media/83601/download
41. U.S. Food and Drug Administration. HPC, Cord Blood Prescribing Information [Internet]. Houston (TX): FDA; 2018 [cited 2025 Apr 26]. Available from: https://www.fda.gov/media/114119/download
42. U.S. Food and Drug Administration. HPC, Cord Blood Prescribing Information [Internet]. Gainesville (FL): FDA; 2013 [cited 2025 Apr 26]. Available from: https://www.fda.gov/media/86321/download
43. U.S. Food and Drug Administration. HPC, Cord Blood Prescribing Information [Internet]. Seattle (WA): FDA; 2016 [cited 2025 Apr 26]. Available from: https://www.fda.gov/media/95521/download
44. U.S. Food and Drug Administration. BREYANZI (Lisocabtagene Maraleucel) Prescribing Information [Internet]. Bothell (WA): FDA; 2021 [cited 2025 Apr 26]. Available from: https://www.fda.gov/media/145711/download
45. U.S. Food and Drug Administration. KYMRIAH (Tisagenlecleucel) Prescribing Information [Internet]. East Hanover (NJ): FDA; 2017 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/107296/download
46. US Food and Drug Administration. YESCARTA® (axicabtagene ciloleucel) prescribing information. Santa Monica, CA: USFDA; 2017 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/108377/download
47. US Food and Drug Administration. TECARTUS™ (brexucabtagene autoleucel) prescribing information. Santa Monica, CA: USFDA; 2020 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/140409/download
48. US Food and Drug Administration. ABECMA® (idecabtagene vicleucel) prescribing information. Summit, NJ: USFDA; 2021 [cited 2025 Apr 24]. Available from: https://www.fda.gov/media/147055/download
49. US Food and Drug Administration. PROVENGE® (sipuleucel-T) prescribing information. Seattle, WA: USFDA; 2010 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/78511/download
50. US Food and Drug Administration. GINTUIT® (allogeneic cultured keratinocytes and fibroblasts in bovine collagen) prescribing information. Canton, MA: USFDA; 2012 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/83264/download
51. US Food and Drug Administration. LAVIV® (azficel-T) prescribing information. Exton, PA: USFDA; 2011 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/80838/download
52. US Food and Drug Administration. MACI® (autologous cultured chondrocytes on porcine collagen membrane) prescribing information. Cambridge, MA: USFDA; 2016 [cited 2025 Apr 28]. Available from: https://www.fda.gov/media/101914/download
53. Hyun I. Allowing innovative stem cell-based therapies outside of clinical trials: ethical and policy challenges. J Law Med Ethics. 2010;38(2):277–85.
54. Dresser R, Frader J. Off-label prescribing: a call for heightened professional and government oversight. J Law Med Ethics. 2009;37(3):476–86.
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Mannan A, Fatima Z, Yamin Salman M. A study on the US FDA Regulatory requirements for Stem Cell Based-Products. Int J Drug Reg Affairs [Internet]. 2025Sep.15 [cited 2025Nov.11];13(3):15-3. Available from: https://www.ijdra.com/index.php/journal/article/view/769
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