FDA Issues New Safeguards for Children in Clinical Trials

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 10 No 7
Volume 10
Issue 7

ROCKVILLE, Md-To comply with a mandate in the Children’s Health Act of 2000, the FDA has issued an interim rule implementing additional requirements to safeguard children enrolled in clinical trials. "A key aspect of the new rule sets standards and procedures for assuring that children have assented to participating in clinical trials (when possible), and that their parents or guardians are able to give fully informed consent to the child’s participation in a study," the agency said in a statement.

ROCKVILLE, Md—To comply with a mandate in the Children’s Health Act of 2000, the FDA has issued an interim rule implementing additional requirements to safeguard children enrolled in clinical trials. "A key aspect of the new rule sets standards and procedures for assuring that children have assented to participating in clinical trials (when possible), and that their parents or guardians are able to give fully informed consent to the child’s participation in a study," the agency said in a statement.

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Recent Videos
Success with the 177Lu-PSMA-617 radioligand therapy would be transformative for the clear cell renal cell carcinoma treatment landscape.
5 experts are featured in this series
4 experts in this video
2 experts are featured in this series.
4 experts in this video
4 experts in this video
4 experts in this video
2 experts are featured in this series.
Related Content