This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

“Designing treatments unique to individual patients has always been the promised goal of personalized medicine. After 25 years the FDA has, for the first time, outlined a framework to facilitate these ...

Scientific, political pressures colliding at FDA, delaying rare disease treatment for patients who have few or no options, experts said at CNBC Cures Summit.

The FDA proposed new guidelines for approving experimental therapies for rare diseases without large group studies.

The FDA already authorizes the use of experimental drugs under what’s called “compassionate use,” for people with no other ...

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...

A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing Thursday on how the ...

The FDA is introducing a new priority voucher program designed to shorten the drug review process from 10 to 12 months down to one or two months, according to the agency. The federal outfit’s ...

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 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 ...

As FDA itself observes, “devices of a new type that FDA has not previously classified … are ‘automatically’ or ‘statutorily’ classified into class III…, regardless of the level of risk they pose.” To ...