Category: Regulations
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FDA Issues Final Biosimilar Guidance
The Food and Drug Administration issued its final guidance on regulating the interchangeability of so-called biosimilars with original biologic drugs.
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Race, Economic Divides Emerge on Opioid Treatments
A new study highlights sharp differences by race and funding of prescriptions for buprenorphine, a promising treatment for opioid use disorder.
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Trial Testing Heart Device Outcomes by Gender
A clinical trial is underway tracking patients with implanted heart devices for 3 years to find any differences in health outcomes between men and women.
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Kidney Diagnostics Receive FDA Breakthrough Tag
An algorithm-driven diagnostic test for chronic kidney disease is receiving a breakthrough device designation from the Food and Drug Administration.
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FDA Approves Transplant Lung Preservation System
The Food and Drug Administration approved a medical device that restores and maintains lungs for transplants that may not otherwise be acceptable.
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Infographic – U.S. Leads in Unvaccinated for Measles
New statistics from Unicef show far more children in the U.S. did not receive their first measles vaccine dose between 2010 and 2017 than children in other countries.
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Lung Model Developed to Test E-Cigarettes, Hookah
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.
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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.