User profiles for Matthew Herder

Matthew Herder

Director, Health Law Institute, Dalhousie University
Verified email at dal.ca
Cited by 780

[HTML][HTML] University technology transfer has failed to improve access to global health products during the COVID-19 pandemic

M Herder, ER Gold, S Murthy - Healthcare Policy, 2022 - ncbi.nlm.nih.gov
Publicly funded research has contributed enormously to many products that were developed
in the face of the COVID-19 pandemic. Yet universities’ technology transfer practices have …

Transparency of regulatory data across the European medicines agency, health Canada, and US food and Drug Administration

…, AT Luxkaranayagam, CJ Morten, M Herder… - Journal of Law …, 2021 - cambridge.org
Based on an analysis of relevant laws and policies, regulator data portals, and information
requests, we find that clinical data, including clinical study reports, submitted to the European …

Pharmaceutical drugs of uncertain value, lifecycle regulation at the US Food and Drug Administration, and institutional incumbency

M Herder - The Milbank Quarterly, 2019 - Wiley Online Library
Policy Points The US Food and Drug Administration (FDA) has in recent years allowed onto
the market several drugs with limited evidence of safety and effectiveness, provided that …

[HTML][HTML] Permissive regulation: A critical review of the regulatory history of buprenorphine formulations in Canada

A Sud, M McGee, B Mintzes, M Herder - International Journal of Drug …, 2022 - Elsevier
Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada
for the treatment of opioid use disorder. The drug is considered an important response to the …

From discovery to delivery: public sector development of the rVSV-ZEBOV Ebola vaccine

M Herder, JE Graham, R Gold - Journal of Law and the …, 2020 - academic.oup.com
The discovery and development of the Ebola rVSV-ZEBOV vaccine challenge the common
assumption that the research and development for innovative therapeutic products and …

[HTML][HTML] What is the purpose of the orphan drug act?

M Herder - PLoS medicine, 2017 - journals.plos.org
Matthew Herder * E-mail: Matthew.… Copyright: © 2017 Matthew Herder. This is an open
access article distributed under the terms of the Creative Commons Attribution License …

[HTML][HTML] From sandbox to pandemic: Agile reform of Canadian drug regulation

IE Vural, M Herder, JE Graham - Health Policy, 2021 - Elsevier
Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators
worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative …

[HTML][HTML] Extending the US Food and Drug Administration's postmarket authorities

HF Lynch, RE Sachs, S Lee, M Herder… - JAMA Health …, 2023 - jamanetwork.com
Importance The US Food and Drug Administration (FDA) has expansive regulatory flexibility
regarding the quality and quantity of evidence it deems sufficient to approve new drugs, …

A responsibility to commercialize? Tracing academic researchers' evolving engagement with the commercialization of biomedical research

K Holloway, M Herder - Journal of Responsible Innovation, 2019 - Taylor & Francis
Governments and academic institutions have embraced the importance of commercializing
research through the late twentieth century. In this study, we seek to understand scientists’ …

Exploring the Food and Drug Administration's review and approval of Entresto (sacubitril/valsartan)

AL Eadie, KR Brunt, M Herder - Pharmacology Research & …, 2021 - Wiley Online Library
Federal regulatory agencies such as the United States Food and Drug Administration
review pharmacological evidence to ensure the safety and efficacy of new and repurposed …