Regulatory Affairs Professionals Society

FDA warns three firms for GMP violations, cites Incyte for misleading claims

The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for ...
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 ...

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 ...
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 ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
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 ...
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.
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 ...
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 ...

FDA approval, fundraising, and the reality of building in healthcare according to BioticsAI founder

BioticsAI CEO Robhy Bustami joined Isabelle Johannessen on Build Mode to discuss how the company has navigated a highly ...