OFFICE OF NEW DRUGS MODULE

In 2000, the International Conference on Harmonisation (ICH) finalized international guidelines that addressed the conduct of clinical trials of medicines in pediatric populations. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm

The guidelines facilitate the safe and effective use of medicinal products in pediatric patients. As a result, FDA adapted this guideline based on the general principles of ICH E-11, including:

• Pediatric patients should be given medicines that have been properly evaluated for use in the pediatric population.
• Product development programs should include pediatric studies when appropriate.
• Pediatric product development should not delay adult studies or the availability of drugs for adult patients.

Apart from the guidance, companies, regulatory authorities, health professionals and society have a shared responsibility for including pediatric patients in drug development.