Regulatory loopholes for research conducted off US soil allow for questionable trials and misleading data to slip under the FDA’s radar.
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Articles on Food and Drug Administration
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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.
The FDA has chosen not to regulate lab-developed tests like the ones at the center of the Theranos trial.
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.
Australia is still aiming to start vaccinating high-risk groups from March. Why the delay?
The new BinaxNOW antigen test is quick, easy, accurate and cheap. It could solve the US testing problem, but the emergency use authorization only allows people with COVID-19 symptoms to get tested.
Testing large numbers of people regularly would reduce the spread of the coronavirus in the US. Laboratory testing is slow and expensive, but rapid screening tests could be the answer.
After firms add more women to their board, dangerous medical products are recalled more quickly.
The FDA has sped up its approval process for coronavirus treatments, creating a new division to expedite the regulatory process. But is safety being sidelined for speed?
Vaccine development is usually a long process. The coronavirus pandemic is forcing researchers to innovate and test potential vaccines faster than ever before.
Every year, thousands of medical devices and drugs are recalled in the US. But the decision to recall a flawed product is often left up to the manufacturer.
Most Americans underestimate how many calories nutritionists recommend they consume each day, which means maybe you can probably have one more treat without feeling guilty.
The Trump administration wants to streamline federal food safety efforts under one roof as part of a sweeping new plan to reorganize government.
Pacemakers are Internet of Things devices for the human body, but they’re still not particularly secure.
Companies are exploiting a knowledge gap with consumers and fears of the supposed health hazards of certain ingredients with so-called absence labels.
Regulatory bodies approved some medical devices to treat pelvic organ prolapse and urinary incontinence before having data to prove their safety and efficacy.
Products not under the FDA’s jurisdiction don’t have to list whether they contain any of the antimicrobial chemicals banned in soap by the agency.
Federal officials could give the FDA authority to develop e-cigarette regulations. But developing regulations that maximize their benefits and minimize their risks is harder than it looks.
Thalidomide’s manufacturer, Chemie Grünenthal, marketed the drug as safe for pregnant women despite reports it was causing malformations in newborns. Why such blatant denial?
Before the last round of negotiations, only a handful of issues remained in the way of concluding the TPP. A potential deal-breaker for Australia was intellectual property protections for biologics.
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Distinguished Professor and Head of the Department of Pharmacy Practice, University of Connecticut
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