Elanco receives FDA warning letter over Zenrelia marketing
Elanco Animal Health (ELAN) has received a warning letter from the FDA related to promotional materials for its canine drug Zenrelia. Read more here.
C&EN1d
Scientists, drugmakers brace for a Kennedy HHS after confirmation
Health scientists and drug industry executives around the world are on alert after the confirmation of Robert F. Kennedy Jr., who spreads antivaccine misinformation and has often derided the ...
FDA clears Outset Medical of previous warning issues
Inc. (NASDAQ:OM), a medical technology company focused on innovating dialysis treatment, has resolved all concerns raised in a Warning Letter from the U.S. Food and Drug Administration (FDA) dating ...
Outset Medical announces resolution of FDA warning letter
Outset Medical (OM) announced it has been notified by the FDA that all issues cited in a warning letter the company received in July of 2023 ...
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FDA Warns People About The Serious Consequences Of Missed Notifications for Diabetes Patients
In this new age of technology, our lives have become heavily tangled with our electronics. Even when it comes to alerts about ...
FDA shares warning on some smartphone-connected diabetes devices
According to the CDC, more than 38 million Americans have diabetes. This warning is for people who use diabetes apps like continuous glucose monitors, insulin pumps, and other diabetes management ...
Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
Senators call on FDA to act against misleading weight-loss drug commercials
Commercials run by the telehealth company Hims & Hers have been placed under the microscope as lawmakers are calling out the advertisement of prescriptions for injectable weight-loss drugs without ...
Anti-Kickback Statute: A Powerful Tool in DOJ’s Corporate Arsenal Grows Stronger
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 ...
Healio2d
AI tool predicts response to, survival after treatment with immune checkpoint inhibitors
An AI tool appeared superior to two FDA-approved biomarkers for predicting how people with cancer will respond to immune ...
EurekAlert!3d
FAIR Health launches Alzheimer’s disease shared decision-making tool and supplementary resources
Today, as part of a national initiative funded by The John A. Hartford Foundation (JAHF), the national, independent nonprofit FAIR Health launched a new shared decision-making tool for Alzheimer’s ...