Home Regulatory Approval News EMA Updates Guideline on Pediatric Investigation Plans

EMA Updates Guideline on Pediatric Investigation Plans

October 22,2025
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The European Medicines Agency has published a revised guideline on PediatricInvestigation Plans, with new requirements for age-appropriate formulations andlong-term safety data collection.

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Comment list (14)

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wangxue

3 weeks ago

@wangxue On Oct 6 2025, AbbVie announced positive topline results from its Phase 2 ELATE trial evaluating onabotulinumtoxinA (BOTOX) for upper limb essential tremor compared to placebo.

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wangxue

3 weeks ago

werewrwerew

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wangxue

3 weeks ago

@wangxue dwqedaws

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wangxue

3 weeks ago

The European Medicines Agency has published a revised guideline on PediatricInvestigation Plans

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wangxue

3 weeks ago

The European Medicines Agency has published a revised guideline on PediatricInvestigation Plans

image

wangxue

3 weeks ago

The European Medicines Agency has published a revised guideline on PediatricInvestigation Plans

image

wangxue

3 weeks ago

The European Medicines Agency has published a revised guideline on PediatricInvestigation Plans

image

wangxue

3 weeks ago

The European Medicines Agency has published a revised guideline on PediatricInvestigation Plans

image

wangxue

3 weeks ago

rewrewrtewtewtpoewktoewtew

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wangxue

3 weeks ago

wrewrewrew