Blood-based traumatic brain injury biomarkers–Clinical utilities and regulatory pathways in the United States, Europe and Canada

KK Wang, JC Munoz Pareja, S Mondello… - Expert review of …, 2021 - Taylor & Francis
Introduction Traumatic brain injury (TBI) is a major global health issue, resulting in
debilitating consequences to families, communities, and health-care systems. Prior research …

Laboratory-developed tests: design of a regulatory strategy in compliance with the international state-of-the-art and the regulation (EU) 2017/746 (EU IVDR [in vitro …

F Spitzenberger, J Patel, I Gebuhr, K Kruttwig… - … innovation & regulatory …, 2022 - Springer
Purpose This study aimed at the development of a regulatory strategy for compliance of
laboratory-developed tests (LDTs) with requirements of the Regulation (EU) 2017/746 (“EU …

Regulation of molecular farming products

PAC Hundleby, MA D'Aoust, C Finkle, J Atkins… - Recombinant Proteins in …, 2022 - Springer
The regulation of molecular farming is a complex topic because plants and plant-based
systems are relative newcomers among the many production platforms available for …

[HTML][HTML] Pay to skip the line: The political economy of digital testing services for HIV and other sexually transmitted infections

KR MacKinnon, E Mykhalovskiy, C Worthington… - Social science & …, 2021 - Elsevier
The value of digital healthcare has been lauded in Canada at local, provincial, and national
levels. Digital medicine is purported to enhance patient access to care while promising cost …

[PDF][PDF] An overview of comprehensive genomic profiling technologies to inform cancer care

S Basharat, K Farah - Canadian Journal of Health …, 2022 - canjhealthtechnol.ca
Purpose The purpose of this Horizon Scan is to present health care stakeholders in Canada
with an overview of information related to liquid biopsy–based comprehensive genomic …

A comparative analysis of non-invasive prenatal testing in Ontario and Quebec: the role of governing style in health technology innovation & adoption

L Saleh, G Parker, M Stevenson, FA Miller - BMC Health Services …, 2023 - Springer
Background While processes of adoption and the impacts of various health technologies
have been extensively studied by health services and policy researchers, the influence of …

Regulatory oversight for research tests and laboratory-developed diagnostics should be more nimble

DM Berry, RS Parekh, MS Irwin - CMAJ, 2019 - Can Med Assoc
We read with interest the CMAJ commentary by Holloway and colleagues1 and agree
enthusiastically with the authors' asser tion that the Canadian regu latory system must be …

Genetic Renaissance: A Legal, Philosophical, and Ethical Examination of Consent Using Autonomy & Privacy in Genetic Testing

K Fedjki - 2023 - uwspace.uwaterloo.ca
Genetic testing has gained traction in the media with the recent Pentagon ban and
continuing increases in public consumption of at-home tests. Public discourse surrounding …

[PDF][PDF] Estudio legal y comercial de la medicina genómica predictiva en México: regulación del diagnóstico

TM Ascencio Carbajal - 2022 - repositorio.cinvestav.mx
La medicina genómica predictiva (MGP) a través de las pruebas de diagnóstico
genético/genómico (PGG), resultan de utilidad para prevenir enfermedades. Sin embargo …

[HTML][HTML] CADTH Horizon Scan An Overview of Comprehensive Genomic Profiling Technologies to Inform Cancer Care

S Basharat, K Farah, J Horton - canjhealthtechnol.ca
Purpose The purpose of this Horizon Scan is to present health care stakeholders in Canada
with an overview of information related to liquid biopsy–based comprehensive genomic …