Improving Pharmaceuticals for Children Act of 2007

Summary

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 deferral of such requirements to submit a timeline for the completion of such studies; and (2) a waiver of such requirements to submit documentation detailing why a pediatric formulation cannot be developed. Considers a supplement to any new drug or biological license application proposing a labeling change as a result of any pediatric assessment to be a priority application or supplement. Requires the Comptroller General to study the effectiveness of federal law in ensuring that medicines used by children are tested and properly labeled.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 6 June 2007

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• Introduced in House (PDF)

  Introduced in House · EN · 6 June 2007

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• Introduced in House

  summary · EN · 6 June 2007

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