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Articles 1 - 30 of 68
Full-Text Articles in Law
Toward A Canadian Right To Repair: Opportunities And Challenges, Anthony D. Rosborough
Toward A Canadian Right To Repair: Opportunities And Challenges, Anthony D. Rosborough
Articles, Book Chapters, & Popular Press
This Article draws a picture of the past, present, and future of the right to repair in Canada. It looks to early successes toward automotive right to repair, challenges faced in proposing consumer protection reforms in Ontario and Quebec, and the utility of a proposed copyright “Technological Protection Measure (TPM) exception” allowing circumvention for repair purposes. In light of right to repair priorities identified by Canada’s current federal government, the Article identifies a selection of reforms that could achieve these goals. Such reforms include creating regulations under the Copyright Act governing the use and implementation of TPMs, passing an exception …
Achieving A (Copy)Right To Repair For The Eu’S Green Economy, Anthony D. Rosborough, Leanne Wiseman, Taina Pihlajarinne
Achieving A (Copy)Right To Repair For The Eu’S Green Economy, Anthony D. Rosborough, Leanne Wiseman, Taina Pihlajarinne
Articles, Book Chapters, & Popular Press
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The Right to Repair is a global movement in favour of rebalancing the relationship between manufacturers and end users of products and devices. As part of the European Union (EU) Green Deal and the Circular Economy Action Plan, EU legislators have made the Right to Repair a key policy aim. To date, however, the EU’s Right to Repair policy focus has been predominantly consumer law–oriented.
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This article sheds light on another key dimension of the Right to Repair—IP (and principally copyright law). It canvasses the ways in which copyright can inhibit repair activities, including curtailing access to repair information and …
Repair As Research: How Copyright Impedes Learning About Devices, Anthony D. Rosborough, Aaron Perzanowski
Repair As Research: How Copyright Impedes Learning About Devices, Anthony D. Rosborough, Aaron Perzanowski
Articles, Book Chapters, & Popular Press
Widespread computerization and ubiquitous smart devices have enabled software-based copyright governance to reach into new domains. Beyond their instrumental utility, these devices are also containers of vast amounts of information in the form of software and technical know-how. Through copyright and anti-circumvention rules, however, this information can be cordoned off and confined to exclusive distribution channels. This can have a significant impact on research. While copyright law traditionally conceives research as the use of expressive works within institutional settings, this paper proposes a broader conceptualization that includes device research, including informal inquiries and DIY activities. Whether for the purposes of …
Zen And The Art Of Repair Manuals: Enabling A Participatory Right To Repair Through An Autonomous Concept Of Eu Copyright Law, Anthony D. Rosborough
Zen And The Art Of Repair Manuals: Enabling A Participatory Right To Repair Through An Autonomous Concept Of Eu Copyright Law, Anthony D. Rosborough
Articles, Book Chapters, & Popular Press
Repair manuals are an essential resource for repairing today’s modern and computerised devices. And though these manuals may contain purely utilitarian and uncopyrightable facts, they often receive copyright protection in their entirety as literary works. This protection can impede community-based efforts toward fostering a culture of participatory repair throughout the EU, including repair cafés and tool libraries. Participatory repair activities provide numerous environmental, social, and economic benefits. This article explores whether directive 2001/29/EC’s exception for “uses in connection with the repair or demonstration of equipment” at Article 5(3)(l) (the “Repair Exception”) may offer an avenue for enabling such non-profit participatory …
Submission To The Province Of Nova Scotia On Its Review Of The Intimate Images And Cyber-Protection Act - Leaf, Suzie Dunn, Rosel Kim
Submission To The Province Of Nova Scotia On Its Review Of The Intimate Images And Cyber-Protection Act - Leaf, Suzie Dunn, Rosel Kim
Reports & Public Policy Documents
The Women’s Legal Education and Action Fund (LEAF) commends the Nova Scotia government for reviewing its Intimate Images and Cyber-protection Act (the Act) and seeking public input for this review. Nova Scotia has been, and continues to be, a leader in Canada for its role in advancing innovative laws and supports for people targeted by technology-facilitated violence (TFV), digital abuse, and the non-consensual distribution of intimate images (NCDII). As these forms of harmful behaviour evolve and become better understood, it is important to revisit this legislation to assess whether it is providing meaningful and accessible responses to such serious social …
Platforms, Encryption, And The Cfaa: The Case Of Whatsapp V Nso Group, Jonathon Penney, Bruce Schneier
Platforms, Encryption, And The Cfaa: The Case Of Whatsapp V Nso Group, Jonathon Penney, Bruce Schneier
Articles, Book Chapters, & Popular Press
End-to-end encryption technology has gone mainstream. But this wider use has led hackers, cybercriminals, foreign governments, and other threat actors to employ creative and novel attacks to compromise or workaround these protections, raising important questions as to how the Computer Fraud and Abuse Act (CFAA), the primary federal anti-hacking statute, is best applied to these new encryption implementations. Now, after the Supreme Court recently narrowed the CFAA’s scope in Van Buren and suggested it favors a code-based approach to liability under the statute, understanding how best to theorize sophisticated code-based access barriers like end-to-end encryption, and their circumvention, is now …
Regulation Of Health-Related Artificial Intelligence In Medical Devices: The Canadian Story, Michael Da Silva, Colleen M. M. Flood, Matthew Herder
Regulation Of Health-Related Artificial Intelligence In Medical Devices: The Canadian Story, Michael Da Silva, Colleen M. M. Flood, Matthew Herder
Articles, Book Chapters, & Popular Press
Artificial Intelligence (AI) may transform Canadian healthcare. The hope is that AI will enable more accurate and efficient care, thereby solving many access, quality, and safety problems. Yet, despite this tantalizing prospect, there are risks of unsafe AI harming patients, algorithmic bias, and threats to privacy. This work begins analysis of whether applicable Canadian laws are up to the task of ensuring Canadians can benefit from effective health-related AI while minimizing AI-related risks. It focuses on Health Canada’s regulation of medical devices, a ‘first line of defence’ that decides which devices are safe, effective, and thus permitted for trade in …
Understanding Chilling Effects, Jonathon Penney
Understanding Chilling Effects, Jonathon Penney
Articles, Book Chapters, & Popular Press
With digital surveillance and censorship on the rise, the amount of data available online unprecedented, and corporate and governmental actors increasingly employing emerging technologies like artificial intelligence (AI), machine learning, and facial recognition technology (FRT) for surveillance and data analytics, concerns about “chilling effects”, that is, the capacity for these activities “chill” or deter people from exercising their rights and freedoms have taken on greater urgency and importance. Yet, there remains a clear dearth in systematic theoretical and empirical work point. This has left significant gaps in understanding. This article has attempted to fill that void, synthesizing theoretical and empirical …
Reducing Barriers To Accessing Administrative Data On Sars-Cov-2 Vaccination For Research, Andrew Mcrae, Patrick Archambault, Patrick Fok, Hana Wiemer, Laurie Morrison, Matthew Herder
Reducing Barriers To Accessing Administrative Data On Sars-Cov-2 Vaccination For Research, Andrew Mcrae, Patrick Archambault, Patrick Fok, Hana Wiemer, Laurie Morrison, Matthew Herder
Articles, Book Chapters, & Popular Press
Public trust in scientific research, especially research regarding vaccines, has proven fragile during the COVID-19 pandemic. To counter abundant misinformation about SARS-CoV-2 vaccines, rigorous, ongoing evaluations of vaccine safety and effectiveness by independent Canadian researchers are important. However, researchers' efforts to conduct timely, national studies of vaccine effectiveness have been hindered by barriers to data sharing that have made it difficult to integrate patients' vaccination status into SARS-CoV-2 clinical and epidemiological studies. Here, McRae et al discuss how a risk-averse data-sharing culture has led to missed opportunities to conduct robust, timely, pan-Canadian SARS-CoV-2 clinical and vaccine effectiveness studies, and outline …
Submission To The Toronto Police Services Board’S Use Of New Artificial Intelligence Technologies Policy- Leaf And The Citizen Lab, Suzie Dunn, Kristen Mj Thomasen, Kate Robertson, Pam Hrick, Cynthia Khoo, Rosel Kim, Ngozi Okidegbe, Christopher Parsons
Submission To The Toronto Police Services Board’S Use Of New Artificial Intelligence Technologies Policy- Leaf And The Citizen Lab, Suzie Dunn, Kristen Mj Thomasen, Kate Robertson, Pam Hrick, Cynthia Khoo, Rosel Kim, Ngozi Okidegbe, Christopher Parsons
Reports & Public Policy Documents
We write as a group of experts in the legal regulation of artificial intelligence (AI), technology-facilitated violence, equality, and the use of AI systems by law enforcement in Canada. We have experience working within academia and legal practice, and are affiliated with LEAF and the Citizen Lab who support this letter.
We reviewed the Toronto Police Services Board Use of New Artificial Intelligence Technologies Policy and provide comments and recommendations focused on the following key observations:
1. Police use of AI technologies must not be seen as inevitable
2. A commitment to protecting equality and human rights must be integrated …
Submission To Canadian Government Consultation On A Modern Copyright Framework For Ai And The Internet Of Things, Sean Flynn, Lucie Guibault, Christian Handke, Joan-Josep Vallbé, Michael Palmedo, Carys Craig, Michael Geist, Joao Pedro Quintais
Submission To Canadian Government Consultation On A Modern Copyright Framework For Ai And The Internet Of Things, Sean Flynn, Lucie Guibault, Christian Handke, Joan-Josep Vallbé, Michael Palmedo, Carys Craig, Michael Geist, Joao Pedro Quintais
Reports & Public Policy Documents
We are grateful for the opportunity to participate in the Canadian Government’s consultation on a modern copyright framework for AI and the Internet of Things. Below, we present some of our research findings relating to the importance of flexibility in copyright law to permit text and data mining (“TDM”). As the consultation paper recognizes, TDM is a critical element of artificial intelligence. Our research supports the adoption of a specific exception for uses of works in TDM to supplement Canada’s existing general fair dealing exception.
Empirical research shows that more publication of citable research takes place in countries with “open” …
A Modern Copyright Framework For The Internet Of Things (Iot): Intellectual Property Scholars' Joint Submission To The Canadian Government Consultation, Pascale Chapdelaine, Anthony D. Rosborough, Aaron Perzanowski, Bita Amani, Sara Bannerman, Carys Craig, Lucie Guibault, Cameron J. Hutchison, Ariel Katz, Alexandra Mogyoros, Graham Reynolds, Teresa Scassa, Myra Tawfik
A Modern Copyright Framework For The Internet Of Things (Iot): Intellectual Property Scholars' Joint Submission To The Canadian Government Consultation, Pascale Chapdelaine, Anthony D. Rosborough, Aaron Perzanowski, Bita Amani, Sara Bannerman, Carys Craig, Lucie Guibault, Cameron J. Hutchison, Ariel Katz, Alexandra Mogyoros, Graham Reynolds, Teresa Scassa, Myra Tawfik
Reports & Public Policy Documents
In response to the Canadian government consultation process on the modernization of the copyright framework launched in the summer 2021, we hereby present our analysis and recommendations concerning the interaction between copyright and the Internet of Things (IoT). The recommendations herein reflect the shared opinion of the intellectual property scholars who are signatories to this brief. They are informed by many combined decades of study, teaching, and practice in Canadian, US, and international intellectual property law.
In what follows, we explain:
•The importance of approaching the questions raised in the consultation with a firm commitment to maintaining the appropriate balance …
A Modern Copyright Framework For Artificial Intelligence: Ip Scholars' Joint Submission To The Canadian Government Consultation, Carys Craig, Bita Amani, Sara Bannerman, Céline Castets-Renard, Pascale Chapdelaine, Lucie Guibault, Gregory R. Hagen, Cameron J. Hutchison, Ariel Katz, Alexandra Mogyoros, Graham Reynolds, Anthony D. Rosborough, Teresa Scassa, Myra Tawfik
A Modern Copyright Framework For Artificial Intelligence: Ip Scholars' Joint Submission To The Canadian Government Consultation, Carys Craig, Bita Amani, Sara Bannerman, Céline Castets-Renard, Pascale Chapdelaine, Lucie Guibault, Gregory R. Hagen, Cameron J. Hutchison, Ariel Katz, Alexandra Mogyoros, Graham Reynolds, Anthony D. Rosborough, Teresa Scassa, Myra Tawfik
Reports & Public Policy Documents
In response to the Canadian government consultation process on the modernization of the copyright framework launched in the summer 2021, we hereby present our analysis and recommendations concerning the interaction between copyright and artificial intelligence (AI). The recommendations herein reflect the shared opinion of the intellectual property scholars who are signatories to this brief. They are informed by many combined decades of study, teaching, and practice in Canadian and international intellectual property law.
In what follows, we explain:
- The importance of approaching the questions raised in the consultation with a firm commitment to maintaining the appropriate balance of rights …
Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder
Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder
Articles, Book Chapters, & Popular Press
Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …
Legislative Options To Address Institutional Objections To Voluntary Assisted Dying In Australia, Ben P. White, Lindy Willmott, Eliana Close, Jocelyn Downie
Legislative Options To Address Institutional Objections To Voluntary Assisted Dying In Australia, Ben P. White, Lindy Willmott, Eliana Close, Jocelyn Downie
Articles, Book Chapters, & Popular Press
Voluntary assisted dying is being considered by parliaments and law reform bodies across Australia. Although individual conscientious objection is routinely considered in these deliberations, an institution’s desire to object to providing voluntary assisted dying has received very little attention. After briefly considering the concept of institutional objection in voluntary assisted dying, this article examines the available (albeit limited) Australian evidence on this practice. Institutional objection is happening in Victoria (where voluntary assisted dying is lawful) and is likely to occur in other Australian states. The article proposes that regulation is needed and presents three models for parliaments and law reformers …
Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder
Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder
Articles, Book Chapters, & Popular Press
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 pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …
Regulating Wave, Tidal And Ocean Thermal Energy, Meinhard Doelle, Theodore Nsoe Adimazoya
Regulating Wave, Tidal And Ocean Thermal Energy, Meinhard Doelle, Theodore Nsoe Adimazoya
Articles, Book Chapters, & Popular Press
Ocean renewable energy sources hold the potential to contribute to the options of low-carbon energy sources and enhance the efforts by the global community to slow down climate change. In this Chapter, we provide a brief background on the current state of technology and development of wave, tidal and ocean thermal energy and consider their potential as forms of renewable energy as well as the potential negative environmental footprints of ocean renewable energy installation and development. Secondly, we examine the relevant international legal and policy framework governing ocean energy, highlighting in particular, the absence of a global legal instrument that …
Factors Affecting Access To Administrative Health Data For Research In Canada: A Study Protocol, Cynthia Kendell, Adrian Levy, Geoff Porter, Elaine Gibson, Robin Urquhart
Factors Affecting Access To Administrative Health Data For Research In Canada: A Study Protocol, Cynthia Kendell, Adrian Levy, Geoff Porter, Elaine Gibson, Robin Urquhart
Articles, Book Chapters, & Popular Press
In Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research.
Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross
Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross
Articles, Book Chapters, & Popular Press
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 Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.
From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham
From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham
Articles, Book Chapters, & Popular Press
Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. …
Consultation On How To Implement Canada's Cusma Commitment To Extend The General Term Of Copyright Protection, Carys Craig, Ariel Katz, Lucie Guibault, Graham Reynolds, Bita Amani, Sara Bannerman, Pascale Chapdelaine, Myra Tawfik, Samuel Trosow
Consultation On How To Implement Canada's Cusma Commitment To Extend The General Term Of Copyright Protection, Carys Craig, Ariel Katz, Lucie Guibault, Graham Reynolds, Bita Amani, Sara Bannerman, Pascale Chapdelaine, Myra Tawfik, Samuel Trosow
Articles, Book Chapters, & Popular Press
As a group of Canadian Intellectual Property Law scholars, we write regarding the Ministers’ recently launched consultation on extending the term of copyright protection in order to meet Canada’s CUSMA commitments. With this letter, which we jointly submit in response to the call for comments, we wish to express our shared concerns about both the proposed term extension and, more immediately, the inappropriately curtailed nature of this consultation process.
Reasonable Expectations Of Privacy In An Era Of Drones And Deepfakes: Expanding The Supreme Court Of Canada’S Decision In R V Jarvis, Suzie Dunn, Kristen Mj Thomasen
Reasonable Expectations Of Privacy In An Era Of Drones And Deepfakes: Expanding The Supreme Court Of Canada’S Decision In R V Jarvis, Suzie Dunn, Kristen Mj Thomasen
Articles, Book Chapters, & Popular Press
Perpetrators of Technology-Facilitated gender-based violence are taking advantage of increasingly automated and sophisticated privacy-invasive tools to carry out their abuse. Whether this be monitoring movements through stalker-ware, using drones to non-consensually film or harass, or manipulating and distributing intimate images online such as deep-fakes and creepshots, invasions of privacy have become a significant form of gender-based violence. Accordingly, our normative and legal concepts of privacy must evolve to counter the harms arising from this misuse of new technology. Canada’s Supreme Court recently addressed Technology-Facilitated violations of privacy in the context of voyeurism in R v Jarvis (2019). The discussion of …
Is It Actually Violence? Framing Technology-Facilitated Abuse As Violence, Suzie Dunn
Is It Actually Violence? Framing Technology-Facilitated Abuse As Violence, Suzie Dunn
Articles, Book Chapters, & Popular Press
When discussing the term “Technology-Facilitated violence” (TFV) it is often asked: “Is it actually violence?” While international human rights standards, such as the United Nations’ Convention on the Elimination of All Forms of Discrimination against Women, have long recognized emotional and psychological abuse as forms of violence, including many forms of technology-facilitated abuse, law makers and the general public continue to grapple with the question of whether certain harmful technology-facilitated behaviors are actually forms of violence. This chapter explores this question in two parts. First, it reviews three theoretical concepts of violence and examines how these concepts apply to technology-facilitated …
Politics Of Adversarial Machine Learning, Kendra Albert, Jonathon Penney, Bruce Schneier, Ram Shankar Siva Kumar
Politics Of Adversarial Machine Learning, Kendra Albert, Jonathon Penney, Bruce Schneier, Ram Shankar Siva Kumar
Articles, Book Chapters, & Popular Press
In addition to their security properties, adversarial machine-learning attacks and defenses have political dimensions. They enable or foreclose certain options for both the subjects of the machine learning systems and for those who deploy them, creating risks for civil liberties and human rights. In this paper, we draw on insights from science and technology studies, anthropology, and human rights literature, to inform how defenses against adversarial attacks can be used to suppress dissent and limit attempts to investigate machine learning systems. To make this concrete, we use real-world examples of how attacks such as perturbation, model inversion, or membership inference …
Ethical Testing In The Real World: Evaluating Physical Testing Of Adversarial Machine Learning, Kendra Albert, Maggie Delano, Jonathon Penney, Afsaneh Ragot, Ram Shankar Siva Kumar
Ethical Testing In The Real World: Evaluating Physical Testing Of Adversarial Machine Learning, Kendra Albert, Maggie Delano, Jonathon Penney, Afsaneh Ragot, Ram Shankar Siva Kumar
Articles, Book Chapters, & Popular Press
This paper critically assesses the adequacy and representativeness of physical domain testing for various adversarial machine learning (ML) attacks against computer vision systems involving human subjects. Many papers that deploy such attacks characterize themselves as “real world.” Despite this framing, however, we found the physical or real-world testing conducted was minimal, provided few details about testing subjects and was often conducted as an afterthought or demonstration. Adversarial ML research without representative trials or testing is an ethical, scientific, and health/safety issue that can cause real harms. We introduce the problem and our methodology, and then critique the physical domain testing …
Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder
Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder
Articles, Book Chapters, & Popular Press
Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …
Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder
Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder
Articles, Book Chapters, & Popular Press
Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …
Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens
Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens
Articles, Book Chapters, & Popular Press
Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …
Introduction, Aldo Chircop, Floris Goerlandt, Claudio Aporta, Ronald Pelot
Introduction, Aldo Chircop, Floris Goerlandt, Claudio Aporta, Ronald Pelot
Articles, Book Chapters, & Popular Press
This chapter introduces a multidisciplinary collection of chapters addressing various aspects of governance of Arctic shipping written by leading international scholars. It investigates how ocean changes and anthropogenic impacts affect our understanding of risk, policy, management and regulation for safe navigation, environment protection, conflict management between ocean uses, and protection of Indigenous peoples’ interests in Canadian Arctic waters. The book is divided in three parts, together providing a multi-faceted and interdisciplinary view on governance of Arctic shipping. The first part addresses conceptual and empirical aspects of risk governance, management, and assessment in the Canadian Arctic. The second part focuses on …
Sustaining Canadian Marine Biodiversity: Policy And Statutory Progress, Jeffrey A. Hutchings, Julia K. Baum, Susanna D. Fuller, Josh Laughren, David Vanderzwaag
Sustaining Canadian Marine Biodiversity: Policy And Statutory Progress, Jeffrey A. Hutchings, Julia K. Baum, Susanna D. Fuller, Josh Laughren, David Vanderzwaag
Articles, Book Chapters, & Popular Press
A 2012 Expert Panel Report on marine biodiversity by the Royal Society of Canada (RSC) concluded that Canada faced significant challenges in achieving sustainable fisheries, regulating aquacul- ture, and accounting for climate change. Relative to many countries, progress by Canada in fulfilling international obligations to sustain biodiversity was deemed poor. To track progress by Canada since 2012, the RSC struck a committee to track policy and statutory developments on matters pertaining to marine biodiversity and to identify policy challenges, and leading options for implementation that lie ahead. The report by the Policy Briefing Committee is presented here. It concluded that …