Theranos promised that a drop of blood could yield many health secrets.
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The FDA has chosen not to regulate lab-developed tests like the ones at the center of the Theranos trial.
Though drug recalls are relatively uncommon in the U.S., reduced inspections increase the likelihood of manufacturing errors that slip through the cracks.
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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?
Easy, fast coronavirus testing is critical to controlling the virus.
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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.
Broad and frequent screening could catch coronavirus cases before they can spread to others.
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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.
Corporate boards with women on them are more likely to recall dangerous products.
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After firms add more women to their board, dangerous medical products are recalled more quickly.
Laboratories around the world are working round the clock to find treatments or a vaccine for COVID-19.
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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?
A coronavirus vaccine is coming, but when?
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Vaccine development is usually a long process. The coronavirus pandemic is forcing researchers to innovate and test potential vaccines faster than ever before.
Nearly all medical product recalls are voluntarily issued by firms, instead of mandated by the FDA.
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.
Go ahead Santa, take a cookie without guilt.
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.
An FDA lab technician inspects food for contaminants in Lenexa, Kansas.
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The Trump administration wants to streamline federal food safety efforts under one roof as part of a sweeping new plan to reorganize government.
Embedded medical devices will continue to be vulnerable to cybersecurity threats. The pacemaker depicted is not made by Abbott’s.
Pacemakers are Internet of Things devices for the human body, but they’re still not particularly secure.
Gluten-free, GMO-free and 100 percent vegan.
Companies are exploiting a knowledge gap with consumers and fears of the supposed health hazards of certain ingredients with so-called absence labels.
Hundreds of women have complained of adverse reactions from transvaginal mesh implants.
Regulatory bodies approved some medical devices to treat pelvic organ prolapse and urinary incontinence before having data to prove their safety and efficacy.
Any antimicrobial chemicals in there?
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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.
A sales clerk exhales vapor while smoking with a vaporizer during a wait for customers at the e-cigarette shop Henley Vaporium in New York.
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 was used by the pregnant women – the population that turned out to be most vulnerable to its risks.
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?
Representatives of the 12 Trans-Pacific Partnership (TPP) member countries at a press conference in Atlanta, after a deal was reached.
EPA/Erik S. Lesser
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.
Tourism isn’t just for sunshine and beaches. It can also be for unapproved medical interventions.
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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…
What if an experimental treatment seems to hold a terminal patient’s only hope?
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On November 4, the state of Arizona will decide whether to join Colorado, Missouri, Louisiana and Michigan in passing so-called right to try laws. If passed, the “Arizona Terminal Patients’ Right To Try…