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

Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drug and biological product 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...