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Woodcock Touts Baby Steps Toward Global Manufacturing Quality Dossier

 
• By Derrick Gingery

Focus of the campaign is the well-established pharmaceutical manufacturing sector, rather than cell and gene therapy production, the US FDA’s principal deputy commissioner said.

convergence
Cell and gene therapy manufacturing likely is too new for regulatory convergence, Janet Woodcock said. • Source: Shutterstock

Janet Woodcock continues to remind regulators that their manufacturing assessments have a lot in common and can converge around one global dossier.

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