JD Supra

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
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 ...
RealClearPolitics

FDA Commissioner Marty Makary: Starting Process To Schedule "7-Hydroxymitragynine" Kratom Extract As Dangerous, Illegal Opioid

FDA Commissioner Marty Makary said at a press conference Tuesday that the federal government is beginning to process to classify 7-Hydroxymitragynine (7-OH-MIT), a kratom extract sold at gas stations ...
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 ...
MobiHealthNews

Q&A: A doctor's opinion on the FDA AI certification process

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...
Benzinga.com

FDA Outlines Process To Speed Up Rare Disease Therapy Approvals

The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare ...

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 ...
BioSpace

Webinar: Aligning With the FDA on a Regulatory Pathway To Avoid Decision Day Surprises

Watch this critical discussion on how regulators and biotech companies can bridge the expectation gap during the regulatory ...
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 ...
Convenience Store News

FDA Streamlines PMTA Process With Improved Web-Based Options

CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
WLKY

FDA official plans to change vaccine approval process

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...