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

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 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 ...

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 ...

At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with ...

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

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 ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

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 ...

The panel is reviewing whether seven peptides should be made more accessible, an RFK Jr. priority.