GlobalData on MSN

FDA’s UDI guidance ‘ambiguity’ could lead to inconsistent implementation

The perceived ambiguity of the US Food and Drug Administration’s (FDA) guidance on Unique Device Identifier (UDI) ...
Targeted Oncology

FDA Draft Guidance Could Change Designs of Future Oncology Clinical Trials

Trials should assess overall survival to evaluate potential harm, with crossover limited to avoid confounding treatment ...

CDRH shares regulatory guidance priorities for the coming 12 months

Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two ...
MedTech Dive

How the FDA’s crackdown on cybersecurity affects medtech firms

MedSec CEO Michelle Jump spoke with MedTech Dive at AdvaMed’s annual meeting about the FDA’s shift from a “carrot” to a ...
St. Louis Post-Dispatch

FDA proposes regulation of e-cigarettes

The Food and Drug Administration will offer a 75-day period to comment on the proposal, which is not final. The agency will evaluate those comments before issuing a final rule but there’s no timetable ...
Becker's Hospital Review

The Health IT Most Likely to be Subjected to FDA Regulation

During a Sept. 4 meeting of the Office of the National Coordinator for Health IT’s HIT Policy Committee, members of a subgroup discussed the health IT likely to be subject to Food and Drug ...

Don’t Judge A Label By Its Cover: The FDA Eyes Clearer Nutrition Info

By creating a new, simple nutrition label that goes on the front-of-package (FOP), the FDA believes they can make nutrition ...
MobiHealthNews

FDA medical app regulation and the art of intended use

With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of ...