AI could review data sets to assist clinical scientists ...

The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.

The FDA is set to implement a pilot program offering bonuses to drug reviewers for expedited evaluations, aiming to improve efficiency amidst ongoing staff turnover and scrutiny.

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 ...

HealthDay News — US health officials are proposing a new way to develop and approve custom-made treatments for people with rare and hard-to-treat conditions.

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to over-the-counter, a rigorous procedure that must demonstrate a patient no longer needs a ...

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 ...

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

The drug would need to be taken long before symptoms first appear—but it could be used to help protect at-risk individuals.