Blood-based traumatic brain injury biomarkers–Clinical utilities and regulatory pathways in the United States, Europe and Canada
Introduction Traumatic brain injury (TBI) is a major global health issue, resulting in
debilitating consequences to families, communities, and health-care systems. Prior research …
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 …
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 …
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
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 …
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 …
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
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 …
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
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 …
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 …
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 …
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 …
with an overview of information related to liquid biopsy–based comprehensive genomic …