“I think one of the big issues of how the FDA regulatory framework works is that it's very rare that the FDA actually tests anything. It's all self-reported testing, by manufacturers that are also selling the product,” says Valisure CEO David Light.
Analytical laboratory Valisure LLC emerged in 2019 when it found a carcinogenic contaminant in OTC and Rx drugs commonly used in the US. It’s asking the Food and Drug Administration to make the testing it and other independent labs conduct a common part of the market.
“I think one of the big issues of how the FDA regulatory framework works is that it's very rare that...
The gut’s microbiome will shape future medical advances, offering personalized therapies and prevention strategies for a wide range of diseases.
A look at new research on the cardiovascular effects of ADHD medications and what it means for clinical care. This article explores the latest clinical and epidemiological research on the cardiovascular effects of medications commonly prescribed for ADHD, examining potential heart-related risks, underlying mechanisms, and their implications for patient safety, clinical decision-making, and long-term treatment strategies across diverse age groups and risk profiles.
Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.
This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to Kenvue's Kevin Whelan.
The gut’s microbiome will shape future medical advances, offering personalized therapies and prevention strategies for a wide range of diseases.
A look at new research on the cardiovascular effects of ADHD medications and what it means for clinical care. This article explores the latest clinical and epidemiological research on the cardiovascular effects of medications commonly prescribed for ADHD, examining potential heart-related risks, underlying mechanisms, and their implications for patient safety, clinical decision-making, and long-term treatment strategies across diverse age groups and risk profiles.
