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 ...

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 ...

On Thursday, the public had the first chance to air their grievances about the FDA’s controversial Commissioner’s National ...

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 ...

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...

The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are ...

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal worker ...

The US pharmaceutical industry has told the US Food and Drug Administration (FDA) that using process models alone is sufficient for assessing batch uniformity in advanced manufacturing. They believe ...

Eli Lilly just released impressive study results for retatrutide, an investigational weight loss drug that targets three ...

Leaving efficacy to doctors would help Americans lead longer, healthier lives.

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 ...