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.
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Regulatory loopholes for research conducted off US soil allow for questionable trials and misleading data to slip under the FDA’s radar.
A new study suggests the market alone will not deter or punish pharmaceutical companies whose products turn out to have adverse effects after they have been approved.
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.
Regulators are currently reviewing the safety and efficacy data of the Pfizer vaccine for five to 11 year olds before deciding whether to approve its use in this age group.
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.
The FDA has chosen not to regulate lab-developed tests like the ones at the center of the Theranos trial.
Only 3.7% of people in the U.S. with hearing difficulty own hearing aids. Thanks to a federal law in progress of being implemented, OTC hearing aids may help bridge the gap.
An FDA panel has voted against recommending approval of a booster COVID-19 shot for the general population – disappointing some public health officials.
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.
An infectious disease doctor explains the science behind COVID-19 vaccines at a level that children – and adults – of all ages can understand.
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?
The FDA has largely lost its ability to regulate the myriad pills, powders and potions that promise to grow muscle, shed body fat and improve your focus.
While emergency use authorization gets vaccines out to the public more quickly, it doesn’t skip any steps that full approval requires.
Researchers are testing an antibody shot to protect people from Lyme disease-causing bacteria.
Ongoing tracking is meant to spot very rare risks – like the connection between the Johnson & Johnson shot and Guillain-Barré syndrome. And it relies on public reporting.
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.
Principais colaboradores
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Distinguished Professor of Pharmacy Practice, University of Connecticut
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Professor of Law, Villanova University
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Associate Professor of Public Policy, University of Maryland, Baltimore County
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Associate Professor of Pharmacy and Therapeutics, University of Pittsburgh
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Associate Professor of Legal Studies and Political Science, UMass Amherst
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Associate Professor of Obstetrics, Gynecology and Gynecologic Surgery, University of California, San Francisco
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Associate Professor of Molecular Medicine, UMass Chan Medical School
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Professor and Dean, School of Public Health, Georgia State University
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Instructor of Human Immunology, Emory University
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Joel Lexchin é um amigo do The Conversation.
Professor Emeritus of Health Policy and Management, York University, Canada
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Associate Professor of Pediatrics, University of Virginia
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Clinical Associate Professor of Pharmacy Practice, Binghamton University, State University of New York
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Associate Professor of Operations and Decision Technologies, Kelley School of Business, Indiana University
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Professor and Director of Quantitative Biosciences Institute & Senior Investigator at the Gladstone Institutes, University of California, San Francisco
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Professor of Law, George Washington University
