The FDA announcement confirms that the U.S. supply of both prescription-only drugs now meets or exceeds the current and ...
In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...
As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...
Acting in the right place at the right time is the key to effective medical treatment with minimal side effects. However, ...
The health authority issued a toxic drug alert for the city on Saturday, January 25th, saying the pills have been linked to “sudden overdoses requiring naloxone and/or hospitalization”.
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
This article discusses the Anti-Kickback Statute and the False Claims Act. "When coupled with the False Claims Act (FCA), the AKS turns into a potent civil enforcement tool that carries many of the ...
An AI tool appeared superior to two FDA-approved biomarkers for predicting how people with cancer will respond to immune ...
how often and how the alerts are delivered (e.g. audible, vibration, text only) through the app on their phone. The FDA has received medical device reports in which users report these alerts are not ...
This recall is part of a nationwide action announced by the Food and Drug Administration (FDA). Gerber has expressed regret over the situation, stating, “The recall was initiated after receiving ...
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