While emergency use authorization gets vaccines out to the public more quickly, it doesn’t skip any steps that full approval requires.
Articles on FDA approval process
Displaying 21 - 29 of 29 articles
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.
COVID-19 has exacerbated a backlog of domestic and foreign drug manufacturing inspections that the FDA is still too short-staffed to adequately deal with.
The new drug is based on the idea that a build-up of amyloid in the brain leads to the disease. But that hypothesis has been under scrutiny lately.
The FDA approved Alzheimer’s disease drug aducanumab despite minimal evidence of its efficacy. Whether this decision ultimately hurts or helps patients depends on data researchers don’t yet have.
The vaccines that will first be used to prevent the spread of COVID-19 will have gone through a special approval process with the FDA. but just what is this expedited process?
Will a vaccine for COVID-19 be safe? Animal testing, human clinical trials and post-approval surveillance give us good grounds to believe that a future approved vaccine will work and be safe.
The rushed emergency approval for a treatment that might help COVID-19 patients has raised questions: Is the FDA abandoning its own guidelines?
As drug prices soar, consumers look for cheaper generics. A recent study showed safety issues in some generics made abroad, however, suggesting that the FDA’s honor system may not be enough to ensure safety.
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