Although Secretary Kennedy promised it months ago, a new rule for the Generally Recognized as Safe process is scheduled to be ...

A version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions. This week, I ...

A group of experts, some of whom work in the peptide industry, said the Food and Drug Administration should allow six ...

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...

The group met on July 24 to vote on whether compounding pharmacies could legally dispense certain peptides.

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...

Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea. Indeed, let’s say there’s nothing else like it. To bring the first tongue ...

The US Food and Drug Administration (FDA) has released a new guidance document pertaining to labeling changes made to pharmaceutical and biological products based on new safety information discovered ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...