S.993 - Federal Government - A bill to improve pediatric research.

A bill to improve pediatric research. 3/27/2007--Introduced. Pediatric Research Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct an applicant seeking to waive submission requirements related to pediatric assessments of the safety and effectiveness of a drug or biological product to submit to the Secretary of Health and Human Services documentation detailing why a pediatric formulation cannot be developed. Requires an applicant seeking to defer submission of some or all of such assessments to submit to the Secretary a timeline for the completion of pediatric studies.Requires the Secretary to create an internal committee to review pediatric assessment requests issued, pediatric assessments conducted, and deferral and waiver requests. Considers a supplement to a new drug or biological license application proposing a labeling change as a result of any pediatric assessments to be a priority supplement. Sets forth dispute resolution [...]

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