Woodcock: The US FDA Sets The Stage For Global Quality Dossiers
New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.
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Jacqueline Corrigan-Curay brings a broad array of policy experience, from trial design to real-world evidence to supply chain and post-market surveillance, to the CDER principal deputy director role, though US FDA is not yet able to articulate exactly what her promotion will entail.
The ICH Management Committee has endorsed four quality topics for revision in its workplan recommended by its Quality Discussion Group, including a groundbreaking new guideline covering the assessment and control of extractables and leachables of drug containers.
Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.