The FDA classification underscores the urgency of the situation and the potential danger posed by the contaminated products.

Certain people risk severe or life-threatening reactions if they consume these products, according to an official alert.

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...

The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.

Octapharma has received approval from the US Food and Drug Administration (FDA) for a new 2-gram (g) formulation of Fibryga ...

The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer ...

The Naox Link in-ear EEG platform is the first of its kind to be cleared for prescription use at home or in healthcare ...