Table 4.

Procedural guidelines for pediatric drug development.

FDA Pediatric Guidelines

• Recommendations for Complying with the Pediatric Rule (Draft Guidance) [8]

• How to Comply with the Pediatric Research Equity Act (Draft Guidance) [14]

• Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act [10]

• The Content and Format for Pediatric Use Supplements [4]

EMA Pediatric Guidelines

• Guideline on the format and content of applications for agreement or modification of a pediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies [25]

• Guideline on the information concerning pediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA) [27]