Issued by:

Guidance Dissemination Office

Office of the Commissioner, Office of Clinical Policy and Programs, Office of Pediatric Therapeutics

Biologics Evaluation and Research Center

Center for Devices and Radiation Health

Center for Drug Evaluation and Research

Clinical investigations in children are essential to obtain data on the safety and effectiveness of medicines, biological products and medical devices in children and to protect children from the risks associated with exposure to medical products that may be dangerous or ineffective. Children are a vulnerable population who cannot consent for themselves and therefore benefit from additional safeguards when participating in a clinical investigation. These safeguards are an essential requirement for initiating and conducting pediatric investigations as part of a medical product development program. This guide describes current FDA thinking regarding ethical considerations for clinical investigations of medicinal products in children.

Submit Comments

Submit comments on this guidance document electronically via Case ID: FDA-2013-S-0610 – Specific electronic submissions for FDA case management staff (i.e., citizen petitions, draft proposed guidance documents, deviations, and other administrative case submissions)

If you cannot submit comments online, please send your written comments to:

Records Management
Food and drug administration
5630 Fisherman’s Lane, Room 1061
Rockville, MD 20852

All comments should be identified by the title of the guide.