A new FDA fast-track program could undermine the agency’s role as a global drug safety authority.
Articles on Drug approval
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Grey-market peptides are becoming mainstream, but evidence of their effectiveness is thin or non-existent.
Before Canada decides to rely on foreign drug regulators to approve new medicines, Health Canada needs to show that it will improve public health.
By extending their monopoly on a drug, companies prevent generics and other competitors from driving down prices. But increasing transparency can help prevent Big Pharma from gaming the patent system.
Excluding pregnant women from drug trials is standard. But medication use during pregnancy has gone up, and many women are using drugs ‘off-label’ – in ways that haven’t been clinically tested and approved.
Diabetes trials are leaving out people who are most affected by diabetes, which creates a series of problems include the greater likelihood of missing rare and potentially dangerous side effects.
The US Food and Drug Administration has just approved the first ever drug to treat frostbite: iloprost.
The federal government’s proposed Agile Licensing drug approval regulations mean Canada will have less information about the risks of new medicines, and higher costs.
Health Canada continues to monitor newly approved drugs to determine if the benefits identified in the pre-market trials hold up to further scrutiny. Canadians need better access to that information.
As the government’s oldest consumer protection agency, the FDA has long butted up against drugmakers, activists and politicians. But undermining its work could be harmful to patient health and safety.
The pharma industry claims lower prescription drug prices will mean less access to new medication for Canadians. It’s an old threat that pits profits against patients’ rights to affordable drugs.
The next step in HIV prevention — long-acting injectable pre-exposure prophylaxis (PrEP) — is not yet available in Canada, a year after its approval in the U.S.
Canada lags behind other developed countries in access to newer antimicrobials. Here’s why that matters, and what can be done about it.
When drugs are taken off the market because they are either unsafe or don’t work, do pharma companies admit that there are problems? Or do they deny the evidence?
FDA approval of aducanumab (Aduhelm) was contentious. Its submission to Health Canada for approval highlights concerns about evidence, independence and transparency in Canada’s drug approval process.
It usually takes 10 years for a new vaccine to complete clinical trials, but we’ve been promised a COVID-19 vaccine in 12 to 18 months. Even if such fast-tracked development is possible, is it wise?
Nexplanon, a long-acting reversible contraceptive that is implanted in the arm for up to three years, is a welcome addition to birth control options in Canada.
National drug regulators use evidence from clinical trials to decide whether new cancer drugs will be approved for use. But these studies are often flawed.
Health Canada proposes to increase fees to the pharmaceutical industry for prescription drug approval. This will compromise drug safety and is a risk to the health of the Canadian public.
Medical tourism is the practice of seeking medical care across international borders. Countries with established medical sectors like the US, Europe, India and Thailand have been traditional destinations…
Top contributors
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Associate professor, Department of Family and Community Medicine, University of Toronto; York University, Canada; University of Sydney
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Assistant Professor, Dalla Lana School of Public Health & Joint Centre for Bioethics, University of Toronto
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Professor of Law and Public Health, The Ohio State University
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Assistant Professor of Oncology at the School of Medicine, Johns Hopkins University
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Clinician-Scientist, St. Michael’s Hospital; Associate Professor, Faculty of Medicine, University of Toronto
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Ontario Research Chair in Bioethics and Public Policy, Queen's University, Ontario
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Professor, Health Sciences, Simon Fraser University
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Professor, Department of Geography, Simon Fraser University
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Director of the Health Justice Institute at the Schulich School of Law, Dalhousie University
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Lecturer in Pharmacology, Lancaster University
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Professor of Economics, University of Calgary
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Professor of Law, Wake Forest University
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Associate professor, School of Public Health, University of Alberta
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Distinguished Professor of Pharmacy Practice, University of Connecticut
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PhD, School of Nursing, Dalhousie University