CMC Regulatory Updates In Brief: Complete Response Tallies And Guidance On Inhalers, Supplements, Liposomes And H2O2
Executive Summary
US FDA attributes 12% of last year's complete responses to manufacturing facility issues. Separately, it proposes a major revision of its 1998 draft guidance on drug quality for metered dose and dry powder inhalers, revises 1999 internal guidance on CMC supplements, and finalizes guidance on CMC considerations for liposomes drafted in 2015, while UK MHRA cautions firms against relying on VHP to sterilize isolator parts.