Regulatory Focus' ongoing series of Regulatory Explainers take complicated regulatory topics and make them simple enough for anyone to understand. In our latest Regulatory Explainer, we ...
The FDA has proposed placing strong warning labels on many over-the-counter painkillers, cautioning patients about the risks of possible liver failure from taking them too often. More than 200 million ...
The US Food and Drug Administration (FDA) has clarified definitions and appropriate reporting of minor label changes for over-the-counter (OTC) drugs in draft guidance expected to reduce regulatory ...
In an essay published in this week’s issue of the New England Journal of Medicine, a trio of medical researchers team up to propose a novel way to trim some of the nation’s ballooning health care ...
This article originally appeared on ProPublica. Senators introduced legislation on Thursday that would require prescription drug labels to identify where the medication was made, adding momentum to a ...
Obesity can alter the action of many types of medications in ways affecting safety and/or efficacy, but this often isn’t mentioned in the labels. Experts in obesity and pharmacology are trying to ...
The FDA has added new warnings to GLP-1 medications such as Ozempic, Wegovy, and Mounjaro about pulmonary aspiration risk ...
A study found that 26% of uncertainties in cancer drug approvals are not included in FDA labels, with 48% being crucial to approval decisions. The FDA's current communication methods, such as drug ...
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