The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...
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 ...
On Thursday, the public had the first chance to air their grievances about the FDA’s controversial Commissioner’s National ...
Sorensen recently reintroduced the bipartisan STOP GAMES Act, legislation aimed at preventing what he describes as "sham" ...
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 ...
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 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 ...
Leaving efficacy to doctors would help Americans lead longer, healthier lives.
The tool aims to reduce planning time and help care teams create more tailored strategies.