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 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 ...

The decision follows a pattern of policy shifts, including the rollback of COVID-19 recommendations and cancellation of mRNA funding.

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 ...

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 ...

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

A federal judge questioned Tuesday whether demand for abortion medication would go away even if he were to force the Trump ...