Category: Regulations
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Ships Are Becoming Safer With Technology
Here are just several big technological developments in safety that future ships may depend on.
-
Blockchain and Science, Not Ready for Prime Time
A panel of data and behavioral scientists envision great potential for blockchain in science, but show few cases of blockchain in use today among researchers.
-
FDA Approves 25 Precision Meds in 2018
An organization advocating for medicines addressing a person’s unique chemical composition rather than disease symptoms says U.S. regulators approved 25 of those drugs in 2018.