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Lung Model Developed to Test E-Cigarettes, Hookah

Juul e-cigarette

A three-dimensional model of a human lung is being developed to test health effects of new trends in smoking, such as electronic cigarettes and hookahs. . . . → Read More: Lung Model Developed to Test E-Cigarettes, Hookah

FDA Expands Evidence Project to Replace Trials

Data and person graphic

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. . . . → Read More: FDA Expands Evidence Project to Replace Trials

FDA Approves Single Dual-Drug Pill for HIV

HIV released from cell

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. . . . → Read More: FDA Approves Single Dual-Drug Pill for HIV

Brain Stimulator Device Cleared for Depression, Insomnia

Cervella system

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. . . . → Read More: Brain Stimulator Device Cleared for Depression, Insomnia

Insulin Pump Shown Difficult for Many Users

MiniMed 670G

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. . . . → Read More: Insulin Pump Shown Difficult for Many Users

FDA Chief Calls Teen Vaping an “Epidemic”

Scott Gottlieb at Brookings Institution

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. . . . → Read More: FDA Chief Calls Teen Vaping an “Epidemic”

Antibacterial Sleeve Protects Against Implant Infections

Heart and major blood vessels

A mesh envelope infused with antibiotics holding an implanted cardiac device is shown in a large-scale clinical trial to reduce the number of infections associated with those devices. . . . → Read More: Antibacterial Sleeve Protects Against Implant Infections

Commentary – Scott Gottlieb’s Legacy

Scott Gottlieb

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. . . . → Read More: Commentary – Scott Gottlieb’s Legacy

Trials Underway Testing Crispr for Blood Disorders

Crispr genome edits illustration

Clinical trials testing the genome editing technique Crispr for sickle cell disease and beta thalassemia, two inherited blood disorders, enrolled and infused their first patients. . . . → Read More: Trials Underway Testing Crispr for Blood Disorders

FDA Drafts Brain-Computer Device Regulatory Guidance

Brain circuits illustration

Food and Drug Administration is releasing for comment regulatory guidance for its review of implanted medical devices that connect human brains to computer systems. . . . → Read More: FDA Drafts Brain-Computer Device Regulatory Guidance