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

The FDA has issued multiple Class I warnings for chocolate products, the highest risk level indicating a reasonable probability of severe health consequences or death. This classification underscores ...

As a someone who's reached for eye drops countless times for my family's dry, irritated eyes during allergy season, I was alarmed to learn of a massive new recall that might be sitting in your ...

Several ground cinnamon products have been added to a nationwide health alert for containing elevated levels of lead, according to the U.S. Food and Drug Administration. Last week, the FDA sent out ...

An unusual about-face that played out at the Food and Drug Administration over the last week illustrated the power of the “Make America Healthy Again” movement, particularly with its focus on “natural ...

Reading vitamin labels can sometimes be a mystifying experience. To help clarify, here are the various FDA vitamin labels and what they all mean.

At the end of last week the FDA posted two draft guidance documents related to digital health. One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical ...

On Monday, US Health and Human Services Secretary Robert F. Kennedy Jr. and US Food and Drug Administration Commissioner Dr. Marty Makary announced that after 20 years, they were righting a medical ...

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from ...

Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...