Category: Regulations
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FDA Expands Evidence Project to Replace Trials
The Food and Drug Administration is expanding a demonstration project with a Boston teaching hospital that tests the value of real world evidence to replace some clinical trials.
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FDA Approves Single Dual-Drug Pill for HIV
The Food and Drug Administration approved a daily pill with 2 drugs to lower viral loads in people with HIV, but who have not yet taken other HIV drugs.
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Brain Stimulator Device Cleared for Depression, Insomnia
A device sending weak electric impulses into the brain from headphones is authorized by the Food and Drug Administration to treat depression, anxiety, and insomnia.
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Insulin Pump Shown Difficult for Many Users
An assessment of a closed-loop insulin pump system shows a sizeable proportion of first-time users stopped using its automated feature because of problems in making it work.
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FDA Chief Calls Teen Vaping an “Epidemic”
The commissioner of the Food and Drug Administration warned that the sharp rise in teen electronic cigarette use is an epidemic threatening the public health.
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Commentary – Scott Gottlieb’s Legacy
During his tenure, FDA issued a number of guidance documents outlining regulatory processes and practices that streamline reviews, yet are still dictated by scientific evidence.
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Infographic – Fastest Growing Measles Outbreaks
Measles, a disease once considered by health authorities to be under control, is making a comeback in many places in the world.
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FDA Drafts Brain-Computer Device Regulatory Guidance
Food and Drug Administration is releasing for comment regulatory guidance for its review of implanted medical devices that connect human brains to computer systems.
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Blockchain Prototype Designed for Clinical Trial Data
A bioinformatics lab developed a prototype system for securely transmitting and storing clinical trial data with blockchain that protects against corrupting trial records.
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How Your Health Care Facility Can Survive a Security Breach
When your private medical history gets into the wrong hands, it can be more than a little unsettling.