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(FDA) has clarified definitions and appropriate reporting of minor label changes for over-the-counter (OTC) drugs in draft guidance expected to reduce regulatory ...

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 ...

Federal law requires every prescription drug to include a document describing dosing guidelines, contraindications, results from clinical trials and safety considerations. But a spate of recent court ...

Participants examined the challenges and opportunities to update oncology drug labeling that is inconsistent with the current evidence base and use in clinical practice. Discussions focused on what ...

A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section provides ...

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 ...

Abilify is a brand-name oral tablet that doctors prescribe for certain mental health disorders, such as schizophrenia. There may be other conditions, such as anxiety, where doctors may use Abilify off ...