US FDA’s Drug Shortage Program On ‘Site Engagement’ To Be Nixed In GDUFA III
Generics industry and FDA also debated inspection policies in lieu of travel and safety restrictions mandated by the pandemic.
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Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.
Records reviews are common now in lieu of an in-person inspection for US generic applications, but more virtual facility checks could be coming soon.