FDA Warns Lymol To Assess Talc Lead Risk Per ICH Q3D; Puts Others On Notice
Executive Summary
A warning letter to firm with legacy talc drug product puts pharmaceutical industry on notice: the US FDA expects applicants to meet requirements agency imposes post-approval for matters like elemental impurities compliance.
You may also be interested in...
Risk Assessments Of New Drug Elemental Impurities Get Mixed Reviews From Regulators
ICH Q3D went into effect in June 2016 for new drugs, but so far doesn't seem to have completely resolved worries about the presence of elemental impurities in drug products.
Forty-Eight US FDA Drug Application Decisions Delayed By Pandemic's Deferred Inspections
US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.
Children’s Hospital Resumes FDA-Funded Study Of PEG 3350 Pediatric Risks
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.