A new FDA fast-track program could undermine the agency’s role as a global drug safety authority.
Articles on FDA approval process
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The psychedelic treatment is moving through the FDA clinical trial process in Colorado and elsewhere.
After pushback, the agency reversed course and agreed to review Moderna’s application after all.
The agency’s plan to change the well-established process for safety testing vaccines is not realistic.
About 4% of dogs and 12% of cats remain unvaccinated against rabies, posing risks for society.
The FDA’s decision shines a light on some of the unique obstacles that psychedelic drugs may face on the path to approval.
Most people don’t know what these labels really mean − and advertisers take advantage of that fact.
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.
From miscarriages to cancer, poor regulation of cosmetics in the US have taken a devastating toll on consumers’ lives. Are European consumers any safer?
Products aimed at sexual dysfunction and weight loss were the most common dietary supplements that contained hidden – and potentially harmful – ingredients.
Moderna will ask the FDA to allow emergency use for its vaccine in children as young as 6 months, a step many parents have been anticipating.
The CDC’s COVID-19 vaccine provider agreement prohibits health care professionals from administering the vaccines in people for whom they are not yet authorized or approved. But this departs from longstanding norms.
Regulatory loopholes for research conducted off US soil allow for questionable trials and misleading data to slip under the FDA’s radar.
An infectious diseases doctor reviews the evidence, discusses hesitancy and concerns about side-effects and explains the overwhelming case for vaccinating five-to-11-year-olds, including his own son.
When making the decision whether to vaccinate children aged five to 11 against COVID-19, regulators in Canada must rely on sound ethics as well as sound science.
Three tobacco-flavored cartridges and a vaping device have been approved by the FDA for sale in the US. It comes after a decadelong debate over e-cigarettes.
In light of mounting research showing the serious risks of contracting COVID-19 during pregnancy, the CDC is re-upping its urgency that pregnant women get their shots.
Subtly shifting the crafting and delivery of public health messaging on COVID-19 vaccines could go a long way toward persuading many of the unvaccinated to get the shot.
Making rapid antigen tests for COVID-19 cheaper and more accessible can catch the infectious cases before they spread and help everyone resume normal activities safely.
The U.S. FDA has approved the first COVID-19 vaccine. How is approval different from emergency use authorization, and what difference will it make to a vaccine that’s already in global use?
Top contributors
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Distinguished Professor of Pharmacy Practice, University of Connecticut
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Professor of medicine, epidemiology & biostatistics, and philosophy, Western University
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Professor of Law, Villanova University
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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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Associate Professor, Infectious Diseases, University of Saskatchewan
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Professor of Law and Louis F. Niezer Faculty Fellow, Indiana University
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Instructor of Human Immunology, Emory University
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Associate Professor of Public Policy, University of Maryland, Baltimore County
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Research Specialist, University of Michigan
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Professor of cognitive pharmacology, Université du Québec à Montréal (UQAM)
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Professor of Law, University of Maryland
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Associate Professor, Nuffield Department of Primary Care Health Sciences, University of Oxford
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Professor and Dean, School of Public Health, Georgia State University
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Clinical Professor of Pharmacy Practice, University of Connecticut
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James P. Jimirro Professor of Media Effects, Co-Director, Media Effects Research Laboratory, & Director, Center for Socially Responsible AI, Penn State