CMC Regulatory Updates In Brief: Complete Response Tallies And Guidance On Inhalers, Supplements, Liposomes And H2O2
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 Separately, it proposes a major revision of its 1998 draft guidance on drug quality for metered dose and dry powder inhalers, revises 1999 internal guidance on CMC supplements, and finalizes guidance on CMC considerations for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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'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.
User fee legislation says facility information to qualify for priority review must arrive two months in advance of ANDA, conflicting with narrow 'window' in FDA's draft guidance.
...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.)