MHRA
MHRA updates marketing authorisation variation guidance
The guidance explains how to apply for changes to a marketing authorisation, including type IA and IB minor variations, type II major variations, and extensions.
Read the official sourceMHRA
MHRA updates guidance for finding medicine product information
The guidance covers access to patient information leaflets, summaries of product characteristics, and public assessment reports.
Read the official sourceFDA
FDA permanently debars Naveed Aslam
FDA permanently debarred Naveed Aslam from providing services in any capacity to a person with an approved or pending drug product application, following a felony conviction related to drug regulation under the FD&C Act.
Read the official sourceFDA
FDA issues 10 year import debarment order for Jeffrey Thies
FDA debarred Jeffrey Thies for 10 years from importing or offering to import any drug into the United States, based on two federal felony convictions involving counterfeit goods and aiding and abetting.
Read the official sourceWhy this matters
The MHRA updates provide current reference points for two recurring regulatory tasks: managing post authorisation changes and locating official medicine information. FDA’s orders also reinforce the consequences of drug related criminal conduct for participation in regulated activities.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.