MobiHealthNews

How the FDA process is biased against new technology

And FDA explains that they don’t have any extra. Congress has been underfunding FDA for decades, and the agency only stays afloat now by virtue of user fees the industry pays to get submissions ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

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 ...
BioSpace

FDA flexibility isn’t absent but evolving regulations come with growing pains

The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare ...
Becker's ASC

FDA contemplates changing approval process for software used as a medical device — 4 insights

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 ...
Becker's Hospital Review

New FDA office will update drug approval process

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 ...
AOL

FDA wants to use AI to speed up drug approval process

FDA officials want more AI in the review process. The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in ...