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.
The Quality Lowdown: ICH Q9, FDA QMM, THC Impurities And Recertified MAPPs
Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.
Valisure’s Message To The FDA: It’s Part Of The Solution, Not Part Of The Problem
CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.