Blog

FDA issues guidance on remote interactive inspections: The FDA has issued draft guidance explaining how it plans to request and conduct voluntary remote interactive evaluations of drug manufacturing sites and other facilities covered by its bioresearch monitoring program. “When facilities agree to participate in a remote interactive evaluation, FDA expects them to cooperate with the same level of transparency as they would during an FDA inspection,” the FDA wrote, adding that it expects staff “to be available at scheduled times for interviews and other virtual interactions, and we expect the facility to be operational to the extent possible for FDA to evaluate areas and operations of interest.”

Blood-based test can help determine cause of fever: A blood-based test that can detect and distinguish 18 different inflammatory or infectious diseases and determine the underlying cause of childhood fever has been developed by an international team of researchers led by Imperial College London scientists. Researchers worked on the test by looking at the gene expression patterns in the blood in response to different diseases.

Spine-tingling science explains why fright is fun: Health experts discuss the biological reasons why human beings get enjoyment from being scared in settings like horror movies and haunted houses. Fright can stimulate the same centers of the brain as happiness and pleasure, and it is enjoyable because there is no real threat of harm. Fear also triggers the release of stress hormones and neurotransmitters that induce a “fight, flight, or freeze” response, an evolutionary development that helped early humans avoid danger.

New app to help patients with Parkinson’s walk better: The “Walking Tall” app was created to help patients with Parkinson’s disease relearn and improve their ability to walk. The app provides audio guidance and encouragement to walk with a smooth gait.

The blood-based test SeekInCare was found to detect more than 20 cancer types, according to a study of patients with and without cancer that was presented at an oncology conference. Test sensitivity varied by cancer type and stage.

Quest Diagnostics has released the AD-Detect test for general consumers to gauge beta amyloid levels, which are associated with neurodegenerative conditions. The test is for anyone “who has a family history of Alzheimer’s disease, is experiencing memory loss, or is experiencing early cognitive decline,” according to Quest.

Breath test to detect COVID-19 produces results in 1 minute: A 3D-printed, portable and adaptable breath test device that can detect SARS-CoV-2 strains has been developed by Washington University in St. Louis researchers. The test requires individuals to breathe into an attached straw two, four or eight times and produces results within 60 seconds.

A Regulatory Affairs Specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light to put their medical devices on the market

Wearable ultrasound can detect tumors, cysts in breasts: A wearable ultrasound patch that can conform to the breast has been developed by researchers to detect abnormalities, such as tumors and cysts. The patch was able to scan for cysts as small as three millimeters during a study

FDA issues warning on unauthorized ultrasound devices: The FDA has warned consumers not to buy or use unauthorized ultrasound medical devices manufactured and sold by Well-Being Reality, CellQuicken, and RoyalVibe Health as these devices have not been reviewed, cleared, or approved by the FDA. People who use the ultrasound devices may experience adverse events such as muscle weakness, nerve damage, pain, scarring, burns and bruising, the Agency said.