FDA/CDC
FDA/CDC
COVID-19 vaccine standards questioned at FDA advisory meeting
Speakers asked for data showing COVID-19 vaccines can prevent serious illness and urged transparency about the agency’s deliberations for each...
FDA/CDC
CDC expands definition of COVID-19 exposure from ‘close contact’
Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place...
FDA/CDC
FDA approves remdesivir, first treatment for COVID-19
The FDA also issued a new EUA for remdesivir allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
FDA/CDC
Migraine nerve stimulation device now available over the counter
The device stimulates the trigeminal nerve using a reusable self-adhesive electrode placed on the forehead.
FDA/CDC
FDA posts COVID vaccine guidance amid White House pushback
In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization,...
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CDC flips, acknowledges aerosol spread of COVID-19
The update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others...
FDA/CDC
FDA orders stronger warnings on benzodiazepines
"While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused," said Commissioner Stephen M. Hahn,...
FDA/CDC
Reworked OxyContin fails to cut overall opioid abuse, FDA panel says
Some members noted that reformulated OxyContin coincided with increased transition to heroin but recognized the difficulty of proving causality....
FDA/CDC
Two PR employees at FDA fired after plasma therapy controversy
The warnings by two public relations experts at the FDA against overpromoting convalescent plasma as a treatment for COVID-19 reportedly led to...
FDA/CDC
Attempted suicide in high school America, 2019
Racial and sexual identity may affect how adolescents act on suicidal thoughts.
FDA/CDC
FDA clears first brain stimulation device to help smokers quit
The company plans a “controlled” U.S. market release of the system for this indication early next year.