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...
Postmarketing Safety Studies: US FDA Defines ‘Good Cause’ For Missing Milestone Dates
A company is in violation for missed PMR milestones unless good cause has been demonstrated for noncompliance. New draft guidance, issued 16 years after the FDA gained the authority to require postmarketing safety studies, provides examples of when good cause exists and encourages sponsors to notify the agency in advance of missed deadlines.
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.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.