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Articles 421 - 434 of 434
Full-Text Articles in Science and Technology Law
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 …
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 …
Editorial, Lucie Guibault
Editorial, Lucie Guibault
Articles, Book Chapters, & Popular Press
1 This issue marks the tenth month into the COVID-19 pandemic. Since March 2020, we have learned to live with the more or less strict public health measures put in place to ‘flatten the curve’ of infection from the virus. Words like ‘social distancing’, ‘mask wearing’, and ‘lockdowns’ have taken an entirely new meaning. In spite of these measures, the human toll is huge, most clearly among frontline workers and vulnerable people. While the curve is far from flat in most countries, the pandemic has brought to light the long time unacknowledged persistence of systemic inequalities: figures show that poorer, …
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 …
Technology-Facilitated Gender-Based Violence: An Overview, Suzie Dunn
Technology-Facilitated Gender-Based Violence: An Overview, Suzie Dunn
Articles, Book Chapters, & Popular Press
Technology facilitated gender-based violence (TFGBV) is a complex worldwide phenomenon with devastating results. Research to date shows that victim-survivors of intimate partner violence are tracked by their abusive partners who use technology to monitor their movements and communication. Many women journalists, human rights defenders and politicians face daily death threats and rape threats for speaking out about equality issues or for simply being a woman in a leadership role. Those with intersecting marginalized identities are at specific risk, with Black, Indigenous, and people of colour, LGBTQ+ people, and people with disabilities facing higher rates of attacks and concerted attacks that …
Legal Risks Of Adversarial Machine Learning Research, Ram Shankar Siva Kumar, Jonathon Penney, Bruce Schneier, Kendra Albert
Legal Risks Of Adversarial Machine Learning Research, Ram Shankar Siva Kumar, Jonathon Penney, Bruce Schneier, Kendra Albert
Articles, Book Chapters, & Popular Press
Adversarial machine learning is the systematic study of how motivated adversaries can compromise the confidentiality, integrity, and availability of machine learning (ML) systems through targeted or blanket attacks. The problem of attacking ML systems is so prevalent that CERT, the federally funded research and development center tasked with studying attacks, issued a broad vulnerability note on how most ML classifiers are vulnerable to adversarial manipulation. Google, IBM, Facebook, and Microsoft have committed to investing in securing machine learning systems. The US and EU are likewise putting security and safety of AI systems as a top priority.
Now, research on adversarial …
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 …
Unscrewing The Future: The Right To Repair And The Circumvention Of Software Tpms In The Eu, Anthony D. Rosborough
Unscrewing The Future: The Right To Repair And The Circumvention Of Software Tpms In The Eu, Anthony D. Rosborough
Articles, Book Chapters, & Popular Press
This analysis examines the impact of software technological protection measures (“TPMs”) in the European Union which inhibit the repair and maintenance of products. Using John Deere tractors as a case study, this analysis addresses the growing number of products which incorporate computerisation and TPMprotected software into their design and function. In utilising software integration and TPMs, many product designs now allow manufacturers to retain considerable control over the manner of repair and choice of technician. In response, consumers and lawmakers are calling for legal reforms to make self-repair and servicing easier. Both the competition law and moral implications of this …
Law Library Blog (January 2020): Legal Beagle's Blog Archive, Roger Williams University School Of Law
Law Library Blog (January 2020): Legal Beagle's Blog Archive, Roger Williams University School Of Law
Law Library Newsletters/Blog
No abstract provided.
The Invalidation Of The Eu-Us Privacy Shield And The Future Of Transatlantic Data Flows: Testimony Of Professor Neil Richards Before The United States Senate, Neil M. Richards
The Invalidation Of The Eu-Us Privacy Shield And The Future Of Transatlantic Data Flows: Testimony Of Professor Neil Richards Before The United States Senate, Neil M. Richards
Scholarship@WashULaw
This is the prepared testimony and statement for the records, including responses to questions for the record of Professor Neil Richards before the United States Senate Commerce Committee on December 9, 2020. The testimony explains that while Congress has failed to pass a comprehensive privacy bill despite many opportunities, the judgment of the European Court of Justice in Data Protection Commissioner v. Facebook, (commonly known as “Schrems 2”) represents a real opportunity for it to do just that in the near future. The testimony argues first that Congress should not just pass a comprehensive privacy bill, but one that gets …
Welcome To Cordell Perspectives, Neil M. Richards, Jonathan W. Heusel
Welcome To Cordell Perspectives, Neil M. Richards, Jonathan W. Heusel
Scholarship@WashULaw
The world around us is changing. Let’s talk about it together. Introducing a series of articles and opinions by the world’s leading experts concerning COVID-19 as it relates to precision medicine and data privacy: Welcome to Cordell Perspectives.