Action 20
Accept and encourage the accelerated steps outlined in Actions 14-18 when evaluating paediatric development plans and reviewing drug applications and encourage formulation development to begin soon after Phase II dosing selection.
Committed by:
SRAs
Sub-Actions & Milestones
Sub-action 20.1

Accept and encourage the accelerated steps outlined in Actions 14-18 when evaluating paediatric development plans and reviewing drug applications. Encourage formulation development to begin soon after Phase II dosing selection.

SRA's

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Milestone 20.1.1

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In a letter to PEPFAR, FDA reiterated its general acceptance of the principles agreed in Rome see attached letter). In May, the FDA issued draft guidance for industry elaborating the same points.

Milestone 20.1.2

Inclusion of acceptance of accelerated steps in EMA Paediatric Committee (PDCO) public note for the record

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WHO asked PDCO to endorse a similar set of principles.

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Updates

Notes

Responsible