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

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

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 ...

Against the backdrop of Rare Disease Day advocates visiting Capitol Hill this week, a Senate panel raised alarm on Thursday ...

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 ...

The FDA plans to establish the Office of Drug Evaluation Science to improve and modernize the review process for new medications, according to STAT. The new office will help develop a standardized ...

Here's what the Moderna flu shot debacle was really about ...

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 ...

Like much of the federal government, the Food and Drug Administration has faced several program cuts and changes under the Trump administration’s sweeping changes to the bureaucracy. In the most ...