Posted by Michael Wonder on 25 Jul 2022
FDA describes plans to expand remote regulatory assessments
22 July 2022 - The US FDA released draft guidance on Friday that formalises its plans for using remote regulatory assessments for FDA regulated products to supplement onsite inspections as it eases out of pandemic response mode.
The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.
