Latest From Bowman Cox
US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.
New FDA assays may show whether polyethylene glycol laxative leaves toxic analytes and metabolites in children with chronic constipation – with potential implications for numerous other products.
US, EU, global authorities share experiences, insights, advice for industry on remote alternatives even after inspectors can resume travels.
Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, say FDA officials..
Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, FDA officials tell the Pink Sheet.
Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.