ICH E11r1 Guideline Clinical Investigation Medicinal Products Pediatric Population
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/ich-e11r1-guideline-clinical-investigation-medicinal-products-pediatric-population
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