BioSpace

FDA Reversals in Rare Disease Space Highlight Confusion Around External Controls

While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external ...
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 ...
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 ...
STAT

How a four-month FDA delay forced a small biotech company to close its doors

In February, a small biotech company reached a breakthrough with the FDA, agreeing to a clinical trial plan. The problem: The ...
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 ...
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 ...

FDA opens door to feedback on ‘unclear’ national priority voucher pathway

The US Food and Drug Administration (FDA) will convene a public hearing intended to obtain feedback on its Commissioner's ...
The National Law Review

FDA Releases Educational Materials on the NDIN Process

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...