HR 2589 · 110th Congress · Health

Improving Pharmaceuticals for Children Act of 2007

Introduced 2007-06-06· Sponsored by Rep. Eshoo, Anna G. [D-CA-14]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2007-06-06)

Plain Language Summary

[AI summary unavailable — showing source text] Improving Pharmaceuticals for Children Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions relating to market exclusivity for pediatric drug studies on new or already approved drugs to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than one year prior to the expiration of such period. Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population if such formulation is not introduced onto the market within one year; and (2) order the labeling of a drug to include information about the results of a pediatric study. Requires the Secretary, acting through the Director of the National Institutes of Heath (NIH), to develop, publish, and revise a priority list of needs in pediatric therapeutics. Revises requirements for the submission of pediatric assessments of the safety and effectiveness of a drug or biological product with a new drug or supplemental application to require an applicant seeking: (1) a d…

Summarized by Claude AI · Non-partisan · For informational purposes only