FDA promotes children clinical trials for drugs, biological products and medical devices. FDA perspective on the ethical considerations for including and protecting children in clinical trials.
And for that purpose, the draft guidance for children who participate in clinical trials is released which intends to assist industry, sponsors and institutional review boards (IRBs).
- Read more about FDA promotes children clinical trials to establish pediatric specific labeling
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source https://www.pharmatutor.org/pharma-news/2022/fda-promotes-children-clinical-trials-to-establish-pediatric-specific-labeling
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