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Book cover for Ophthalmic Biomaterials
Biomaterials Science Series
Ophthalmic BiomaterialsCheck Access
Edited by
Laura Wells
Laura Wells
Queen's University, Canada
  https://orcid.org/0000-0002-7524-2798
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Heather Sheardown
Heather Sheardown
McMaster University, Canada
  https://orcid.org/0000-0002-5404-635X
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Volume
20
DOI:
https://doi.org/10.1039/9781839169779
Hardback ISBN:
978-1-83916-441-5
PDF ISBN:
978-1-83916-977-9
EPUB ISBN:
978-1-83916-978-6
Special Collection: 2025 eBook Collection
No. of Pages:
510
Publication date:
11 Jun 2025
Book Chapter

Chapter 15: Negotiating the Regulatory Pathway Check Access

By
Patrick Bedford
Patrick Bedford
aweCANreg Consulting Group Inc., Waterdown, Ontario, Canada†
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;
Cristina Bostan
Cristina Bostan
bMaisonneuve-Rosemont Hospital Research Centre, Montreal, Quebec, Canada
cDepartment of Ophthalmology, Université de Montréal, Montreal, Quebec, Canada
dCentre universitaire d’ophtalmologie de l’Université de Montréal at the Maisonneuve Rosemont Hospital, Montreal, Canada†
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;
May Griffith
May Griffith
bMaisonneuve-Rosemont Hospital Research Centre, Montreal, Quebec, Canada
eInstitute of Biomedical Engineering, Université de Montréal, Montreal, Quebec, Canada[email protected]
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Doi:
https://doi.org/10.1039/9781839169779-00444
Page range:
444 - 475

New biomaterials are now entering clinical application in a range of applications from cell-free implants to combination biomaterial–therapeutic cells, biomaterial–drug combinations, and more. While regulatory guidelines are continuously evolving, here we discuss several general concepts that will help in navigating the regulatory and translational pathways in developing bioengineered scaffolds, implants and injectables for therapeutic use in the eye.

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