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

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 ...

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 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.

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

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 ...

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 ...