3.0.0 2589 2023-01-12T17:53:04Z 2023-01-12T17:53:04Z House H HR 2007-06-06 110 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2007-06-06T20:09:11Z Referred to 2007-06-06T14:02:25Z 2007-06-06 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2007-06-06 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2007-06-06 Introduced in House IntroReferral Intro-H 9 Library of Congress 2007-06-06 Introduced in House IntroReferral 1000 9 Library of Congress E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 N Health Administrative remedies Child health Clinical trials Commerce Congress Congressional investigations Department of Health and Human Services Drug approvals Drug industry Drugs Families Food and Drug Administration (FDA) Government Operations and Politics Government paperwork Government publicity Intellectual property Labeling Law Licenses Medical research Patents Science, Technology, Communications Health 00 2007-06-06 Introduced in House 2007-08-28T19:14:50Z 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.

]]> Improving Pharmaceuticals for Children Act of 2007 Display Title Improving Pharmaceuticals for Children Act of 2007 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize and amend the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Introduced in House IH Short Titles as Introduced Improving Pharmaceuticals for Children Act of 2007 Introduced in House 2007-06-06T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr2589ih/xml/BILLS-110hr2589ih.xml 2007-06-06 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.