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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 Separately, it proposes a major revision of its 1998 draft guidance on drug quality for metered dose and dry powder inhalers, revises 1999 internal guidance on CMC supplements, and finalizes guidance on CMC considerations for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.

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...draft guidances from FDA have prompted industry to urge a more flexible regulatory approach in this area. The comments on the new oral/nasal inhalation dosage form guidances represent a consensus industry view of "good practices" for CMC regulatory policy development. Industry is concerned that FDA is taking an overly conservative posture that would hamper technological innovation. FDA, on the other hand, points to the susceptibility of inhalation products to quality problems as justifying a conservative approach. A recent public workshop on inhalation product CMC fuels the debate. (An analysis of inhalation product recall and GMP compliance problems over the past five years is included.)





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