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Today, the U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products and medical devices.
Historically, children were not included in clinical trials because of a misperception that excluding them from research was in fact protecting them. This resulted in many FDA-approved, licensed, cleared or authorized drugs, biological products, and medical devices lacking pediatric-specific labeling information. If the medical product was the best available treatment option for the child, doctors were left with no choice but to use a product that had not been reviewed by the FDA for safety and effectiveness in children. It became clear that children can be better protected by including them in clinical research.
The public can provide comments on the draft guidance. Any comments should be submitted within 90 days to ensure that the agency considers them when finalizing the draft guidance. The FDA remains committed to protecting children in clinical trials and assuring the safety and effectiveness of medical products for children.
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