The US Food and Drug Administration has been quietly laying the groundwork for what Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, sees as the only way to resolve the growing problem of conflicting international pharmaceutical manufacturing quality requirements – establishing a global quality dossier.
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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