FDA set to pilot test real-time tracking of clinical trials

The Food and Drug Administration (FDA) is set to pilot test real-time clinical trials in the hopes of expediting results and ...
Neurology Advisor

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

The FDA is testing real-time clinical trial reporting in an effort to speed up the drug review and approval process.
JD Supra

Court gives new life to the post-CRL administrative hearing process, rules that FDA can deny hearing only when evidence is ‘conclusively deficient’

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
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 ...
Regulatory Affairs Professionals Society

FDA cites firms for CGMP violations, failure to submit PMA application

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
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 ...
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 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 ...
STATOpinion

Mifepristone court ruling makes drug development riskier for everyone

The 5th Circuit’s ruling on mifepristone “is bad for health care access, and it’s also bad for innovation,” writes Grace E.
Medscape

FDA's 510(k) System Should Be Scrapped, IOM Concludes

July 29, 2011 (Washington, DC) — The FDA's 510(k) process for clearing putatively moderate-risk devices has been criticized by some for being too lax and by others for obstructing innovation. Now, a ...