FDA final Rule Rejects Parental Waivers and Final Document

At the end of February, FDA released a final rule, entitled “Additional Safeguards for Children in Clinical Investigations of Food and Drug Administrated-Regulated Products.” The final rule says that FDA will not allow waivers of parental or guardian permission for children in clinical trials in most circumstances. Taking over 10 years to settle, this rule finalizes the interim rule published in 2001, which brought FDA regulations into compliance with provisions of the Children’s Health Act of 2000. The final rule also contains refined definitions for guardian and permission, as well as additional clarifications. To read the final rule, click here. Need help with a pediatric clinical study? Contact us at 317.899.9341.