Industry ICH Proposal Would Limit International Regulatory Oversight Of Manufacturing Models
The focus would be on high-impact changes to high-impact models under approach advocated by BioPhorum, IQ Consortium and PPAR.
You may also be interested in...
The ‘established conditions’ concept enshrined in the ICH Q12 draft guideline was the US FDA’s answer to the background information that has cluttered new drug applications in the quality-by-design era. But early indications are that it will amass information clutter of its own.
An industry team is talking up the potential role of what it’s calling ‘regulatory commitments’ to prospectively manage post-approval changes in a way that’s more consistent worldwide. FDA has responded with interest and is engaged in discussions on the idea.
US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.