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FDA is proposing requirements for the content of initial pediatric study plans required to be submitted under the Pediatric Research Equity Act (PREA) which requires sponsors of certain applications to submit a plan for studying their drug/biologic in pediatric patients a primary factor in the increased ability to provide labeling and other drug information for pediatric patients for many more drug and biological products. Developing drugs for pediatric populations present unique challenges for drug manufacturers.  Although the plans are required to be submitted based on the statutory provision, a regulation is required and will provide clarity, specificity, and direction to sponsors, as well as assist FDA in ensuring compliance, and ultimately help to better advance the study of drugs in pediatric populations to support advancing pediatric indications.  

Overall Description of Deadline: Under section 506 of FDASIA, the proposed rule must be promulgated by July 9, 2013.