|Articles|July 1, 2001

Oncology NEWS International

  • Oncology NEWS International Vol 10 No 7
  • Volume 10
  • Issue 7

FDA Issues New Safeguards for Children in Clinical Trials

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.

Articles in this issue

almost 25 years ago

NCI to Expand Its Support for Trials of STI-571

almost 25 years ago

Patients and Physicians Differ on Chemotherapy Expectations

almost 25 years ago

Neoadjuvant Weekly Paclitaxel Ups Breast Cancer Pathologic Complete Response Rates

almost 25 years ago

Concurrent Chemoradiotherapy Helps Preserve Larynx

almost 25 years ago

Once-Daily, Rapid-Onset Morphine Offers Alternative for Those in Severe Pain

almost 25 years ago

Decision Board Helps Breast Cancer Patients Assess Chemotherapy Options, Increases Satisfaction

almost 25 years ago

Over 20% of Breast Cancer Patients Risk Recurrence by Not Taking Their Tamoxifen

almost 25 years ago

Selective Serotonin Reuptake Inhibitors Can Successfully Treat Depression But Not Fatigue in Cancer Patients

almost 25 years ago

Leukemia Society Offers Patient Information on Use of STI-571

almost 25 years ago

Hiking Cigarette Prices Discourages Teens From Taking Up the Habit

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