At FDA's request, the Justice Department sued Laclede Inc. of Rancho Dominguez, California and its president, seeking a permanent injunction against four unapproved Luvena prebiotic vaginal products. FDA says it has told the company since 2010 that approval is required.
Section archive
Page 46 of 288
Health News
Drugs, disease, healthcare, government and lifestyle: health news beyond the plate.
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Miscellaneous
WellCare Acquires Certain Assets from Healthfirst New Jersey
WellCare's New Jersey subsidiary completed its purchase of Medicaid assets from Healthfirst Health Plan of New Jersey, covering about 42,000 members expected to move to WellCare's plan. Terms were not disclosed and 2014 benefits will not change.
Miscellaneous
The Lab for These FDA Scientists Is a Computer Screen
At FDA's National Center for Toxicological Research in Jefferson, Arkansas, the Division of Bioinformatics and Biostatistics collects and analyzes existing research data rather than repeating experiments, aiming to answer questions such as how to keep drug use safe.
Miscellaneous
CDER SBIA Webinar on “Overview of FDA’s Proprietary Name Review Process”
A notice for a CDER Small Business and Industry Assistance webinar on FDA's proprietary name review process, covering draft guidance meant to help sponsors develop drug brand names that are not misleading and do not contribute to medication errors.
Miscellaneous
Four-year, $43 million initiative engages broad expertise in study of mystery conditions
NIH awarded grants to six medical centers to join its Undiagnosed Diseases Network, a four-year, $43 million effort to evaluate and investigate patients whose conditions have gone undiagnosed for years. It builds on a pilot program at the NIH Clinical Center.
Miscellaneous
Mammography Update: MQSA National Statistics
FDA's MQSA scorecard lists 8,691 certified mammography facilities and 13,612 accredited units. Among facilities inspected in fiscal 2014, 86.9 percent had no violation and 0.4 percent had a Level 1 violation. Facilities reported 38,813,874 procedures a year.
Miscellaneous
FY2014 PHEP and HPP Funding
HHS awarded more than $840 million for fiscal 2014 to state and local preparedness efforts: $228.5 million through the Hospital Preparedness Program and $611.75 million through Public Health Emergency Preparedness, to sustain response capacity for outbreaks and disasters.
Miscellaneous
ImmunID Announces Agreement with the Singapore Immunology Network (SIgN) to Study Immune Competence
ImmunID agreed to use its ImmunTraCkeR and ImmunIG tests to measure T and B immune repertoire diversity in blood from patients in a clinical trial led by Singapore's SIgN. Both sides say the collaboration should show how immune competence affects health outcomes.
Miscellaneous
FDA outlines expectations for human drug compounders, including registered outsourcing facilities
The FDA issued several compounding policy documents: draft interim guidance on good manufacturing practice for registered outsourcing facilities, a final guidance, two revised requests for bulk drug substance nominations, and a proposed rule adding 25 products to the do-not-compound list.
Environment
Fireworks Laws by State
A summary current to June 1, 2014: most states permit some or all consumer fireworks, Illinois, Iowa and Maine allow only sparklers and novelties, Arizona only novelties, and Delaware and Massachusetts ban consumer fireworks entirely.
Lifestyle
Short sleep, aging brain
Duke-NUS researchers tracked 66 older Chinese adults with MRI scans and cognitive tests every two years and found that those sleeping fewer hours showed faster brain ventricle enlargement and steeper decline in cognitive performance. The work appeared in SLEEP.
Miscellaneous
New Healthcare Social Network Connects Users to Best Providers, Treatments and Medications Based on Past Patient Experience
NeedMe Inc. launched a healthcare social network that anonymously links newly diagnosed patients with past patients who had the same conditions, tests and treatments at the same locations. The company says 79% of newly diagnosed people search online for answers.
Miscellaneous
Superbug-Slaying Robot TRU-D Arrives At Covenant and Sartori Medical Centers
Wheaton Franciscan Healthcare-Iowa has deployed TRU-D SmartUVC at Covenant Medical Center in Waterloo and Sartori Medical Center in Cedar Falls. Its Sensor360 technology measures reflected UVC and calculates the dose needed, and cloud software now logs the disinfection data.
Miscellaneous
Ameritox Sponsors Youth Basketball Camps Focused on Drug Abuse Prevention
Ameritox is sponsoring Operation UNITE's “Shoot Hoops, Not Drugs” summer basketball camps in rural Kentucky, which pair skills instruction with drug-abuse prevention. The release says drug-related deaths in the state number more than 100 each month.
Miscellaneous
Survey: Young Women Underestimate Heart Disease
In a Google survey of 3,304 women commissioned by a Massachusetts malpractice attorney, 61 percent correctly named heart disease as the leading cause of death among US women. Among those aged 18 to 24, 43 percent picked cancer instead.
Miscellaneous
NIH-commissioned Census Bureau report highlights effect of aging boomers
A Census Bureau report commissioned by NIH finds smoking and heavy drinking have declined among older Americans while chronic disease has risen, and many are unprepared to pay for nursing home care. The over-65 population, now above 40 million, could reach 83.7 million by 2050.
Miscellaneous
FDA Secures Full Industry Engagement on Antimicrobial Resistance Strategy
All 26 drug sponsors covering 283 affected applications have now agreed in writing to phase out production uses of medically important antimicrobials in food animals and put remaining therapeutic uses under veterinary oversight, FDA says in its first six-month progress report on GFI #213.
Environment
Lead in kids' blood linked with behavioral and emotional problems
NIEHS-funded research in JAMA Pediatrics tied blood lead levels in more than 1,300 Chinese preschoolers, averaging 6.4 micrograms per deciliter, to greater risk of anxiety, depression and aggression, with problems increasing as lead levels rose.
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