To amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients.

[AI summary unavailable — showing source text] Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drugs and biological products to assess such drug's or product's safety and effectiveness for relevant pediatric subpopulations, including dosage. Permits extrapolation from adult studies where the course of the disease and the effects of the drug are sufficiently similar in all populations. Permits deferral of such assessments if adult studies are completed earlier and the applicant submits a plan for or a description of planned or ongoing pediatric studies. Permits full waiver of such assessments if: (1) studies are highly impractical or impossible; (2) the evidence strongly suggests that the drug or product would be ineffective or unsafe in all pediatric age groups; (3) there is no meaningful therapeutic advantage or benefit in the pediatric population; or (4) the drug or product is not likely to be used in a substantial number of pediatric patients. Permits partial waivers at the request of an applicant for a specific pediatric subpopulation if any of the full waiver grounds apply to that subpopulation or reasonable attempts for a pediatric formulation for that subpopulation have failed. Req…