FDA
FDA schedules public discussion on pathogen-agnostic sequencing
FDA announced an open advisory committee meeting on pathogen-agnostic sequencing in emergency preparedness and response, and established a docket for public comment.
Read the official sourceFDA
Biological product deviation reporting collection advances to OMB review
FDA submitted its proposed information collection covering biological product deviations and human cell, tissue, and cellular and tissue-based product manufacturing deviations to OMB for review and clearance.
Read the official sourceMHRA
MHRA invites views on AI in medicines development
MHRA and the Regulatory Innovation Office opened a stakeholder survey seeking organizational views on the use of AI in medicines development.
Read the official sourceMHRA
MHRA publishes GCP inspection information
MHRA published guidance containing information about good clinical practice inspections for medicines trials.
Read the official sourceWhy this matters
Regulatory affairs teams have two opportunities to follow developing authority thinking on sequencing and AI, alongside practical information on GCP inspections and the administrative framework for deviation reporting. The FDA advisory process and MHRA survey are especially relevant for monitoring how regulators assess emerging technologies before future policy positions take shape.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.