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Edwards Lifesciences Seeks Director for Global Brand Marketing to Lead Product Launches and Portfolio Strategy

Edwards Lifesciences Seeks Director for Global Brand Marketing to Lead Product Launches and Portfolio Strategy

Edwards Lifesciences Seeks Director for Global Brand Marketing to Lead Product Launches and Portfolio Strategy
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Vital Signs Research Group Conducts FDA-Compliant Glucometer Testing and Validation Studies in San Francisco

Vital Signs Research Group Conducts FDA-Compliant Glucometer Testing and Validation Studies in San Francisco

Vital Signs Research Group, located in San Francisco, CA, is actively conducting glucometer testing and validation studies to meet stringent FDA accuracy requirements for blood glucose monitoring devices. These studies are crucial for manufacturers seeking FDA 510(k) clearance for their products, which range from traditional fingerstick glucometers to continuous glucose monitoring (CGM) adjacent devices. The research group designs clinical studies tailored to the specific intended use, target population, and regulatory pathway of each device. Their testing protocols align with FDA guidance on blood glucose monitors and applicable ISO 15197 accuracy standards for non-significant risk devices. All studies are reviewed and approved by an external Institutional Review Board (IRB), Advarra, and adhere to ISO 14155, FDA 21 CFR 50, and FDA 21 CFR 812 regulations. The company recruits study participants from a pre-screened database, ensuring a diverse range of glucose levels and demographics to meet FDA requiremen...
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FDA Guidelines on Caffeine Intake Emphasized for Pre-Workout Energy Drinks

FDA Guidelines on Caffeine Intake Emphasized for Pre-Workout Energy Drinks

FDA Guidelines on Caffeine Intake Emphasized for Pre-Workout Energy Drinks
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Multiple Avenues Available for U.S. Citizens to Secure Health Insurance Coverage

Multiple Avenues Available for U.S. Citizens to Secure Health Insurance Coverage

U.S. residents have several primary options for obtaining health insurance, catering to various employment statuses, income levels, and age groups. The most common and often most affordable method is through an employer-sponsored group health insurance plan, typically available to full-time employees and their families. For individuals without employer coverage, the HealthCare.gov marketplace, also known as 'Obamacare' or Affordable Care Act (ACA) plans, offers a range of private health insurance options with potential subsidies for lower-income individuals. These marketplace plans are categorized into metal tiers (Catastrophic, Bronze, Silver, Gold, Platinum) based on cost-sharing. Government programs like Medicare serve individuals over 65 or those with qualifying disabilities, while Medicaid provides coverage for low-income individuals and families. Additionally, short-term health insurance plans are available for temporary coverage needs, though they may not offer the same comprehensive benefits as mar...
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Eli Lilly Secures Two FDA Approvals and Major Drug Discovery Alliance

Eli Lilly Secures Two FDA Approvals and Major Drug Discovery Alliance

Eli Lilly Secures Two FDA Approvals and Major Drug Discovery Alliance
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Popular Walmart frozen meal recalled over possible listeria

Popular Walmart frozen meal recalled over possible listeria

Gias Foods pulled two lots of a Walmart store-brand food after state testing flagged listeria, and the expiration dates run into 2027.
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Senator Maggie Hassan Questions FDA Nominee Heidi Overton on Acetaminophen and Autism Link

Senator Maggie Hassan Questions FDA Nominee Heidi Overton on Acetaminophen and Autism Link

During a Senate committee confirmation hearing, Senator Maggie Hassan, a Democrat from New Hampshire, questioned Dr. Heidi Overton, President Trump's nominee for Food and Drug Administration (FDA) commissioner, regarding the President's claims about a link between acetaminophen use during pregnancy and autism. Senator Hassan specifically asked Dr. Overton if she believed Tylenol causes autism. Dr. Overton responded that she had not seen any causal evidence to support such a link and noted that the Tylenol label recommends pregnant women consult their doctors. When pressed on whether President Trump was incorrect in his assertions, Dr. Overton declined to answer directly. This line of questioning followed concerns raised by other senators, including Senator Bill Cassidy, R-La., and Senator Bernie Sanders, I-Vt., about Dr. Overton's scientific judgment and her willingness to challenge the President on policy decisions, particularly concerning vaccine schedules and the abortion drug mifepristone. Dr. Overton ...
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Deaths of students at the University of Mississippi cast spotlight on kratom

Deaths of students at the University of Mississippi cast spotlight on kratom

A drug task force in Mississippi is urging people to avoid kratom after authorities found packages of the substance while investigating the deaths of two University of Mississippi students
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Zenzi Pharmaceutical Placed on Import Alert by FDA Following Failure to Respond to Records Requests

Zenzi Pharmaceutical Placed on Import Alert by FDA Following Failure to Respond to Records Requests

Zenzi Pharmaceutical Placed on Import Alert by FDA Following Failure to Respond to Records Requests
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FDA nominee voices support for vaccines at Senate hearing scrutinizing Trump administration efforts

FDA nominee voices support for vaccines at Senate hearing scrutinizing Trump administration efforts

President Donald Trump’s nominee to lead the Food and Drug Administration is voicing support for the safety of vaccines
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FDA nominee says vaccines are safe despite Trump efforts to overhaul childhood shots

FDA nominee says vaccines are safe despite Trump efforts to overhaul childhood shots

President Donald Trump’s nominee to lead the Food and Drug Administration is voicing support for the safety of vaccines
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CDC vaccine recommendations are at a standstill, and unanswered questions are piling up

CDC vaccine recommendations are at a standstill, and unanswered questions are piling up

The Centers for Disease Control and Prevention’s vaccine recommendation process has been blown up in the past year, and decision-making has ground to a halt