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New FDA guidance offers an ethical roadmap for including children in clinical trials (Gene and Cell Catapult Regulatory Round-up – September 2022)

Today, the U.S. Food and Drug Administration issued draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials.

The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of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. The guidance was developed by the FDA’s Office of Pediatric Therapeutics with contributions from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health.

The public can provide comments on the draft guidance, however these should be submitted within 90 days to ensure that the agency considers them when finalizing the draft guidance.

See all of the Gene and Cell Catapult’s regulatory round-up for september 2022 here. Published on the 4th of October 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (30 novembre 2022). New FDA guidance offers an ethical roadmap for including children in clinical trials (Gene and Cell Catapult Regulatory Round-up – September 2022). ELSIBI. Consulté le 18 février 2025 à l’adresse https://doi.org/10.58079/o65o


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