3.0.0 993 2023-01-11T19:45:20Z 2023-01-11T19:45:20Z Senate S S 2007-03-27 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-03-27T20:06:42Z 2007-03-27 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2007-03-27 Sponsor introductory remarks on measure. (CR S3842) IntroReferral B00100 9 Library of Congress 2007-03-27 Introduced in Senate IntroReferral 10000 9 Library of Congress C001041 Sen. Clinton, Hillary Rodham [D-NY] HILLARY CLINTON D NY R N D000388 Sen. Dodd, Christopher J. [D-CT] CHRISTOPHER DODD D CT JOHN 2007-03-27 True Health Child health Commerce Congress Congressional investigations Congressional reporting requirements Drug approvals Families Government Operations and Politics Government paperwork Governmental investigations Labeling Pharmaceutical research Science, Technology, Communications Health 00 2007-03-27 Introduced in Senate 2007-07-02T17:22:51Z Pediatric Research Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct an applicant seeking to waive submission requirements related to pediatric assessments of the safety and effectiveness of a drug or biological product to submit to the Secretary of Health and Human Services documentation detailing why a pediatric formulation cannot be developed.

Requires an applicant seeking to defer submission of some or all of such assessments to submit to the Secretary a timeline for the completion of pediatric studies.

Requires the Secretary to create an internal committee to review pediatric assessment requests issued, pediatric assessments conducted, and deferral and waiver requests.

Considers a supplement to a new drug or biological license application proposing a labeling change as a result of any pediatric assessments to be a priority supplement. Sets forth dispute resolution procedures for labeling changes for pediatric drugs.

Requires the Commissioner of the Food and Drug Administration (FDA) to make available to the public the medical, statistical, and clinical pharmacology reviews of pediatric assessments.

Requires the Secretary to: (1) require sponsors of the assessments that result in labeling changes to distribute such information to physicians and other health care providers; (2) ensure that all adverse event reports that have been received for such a drug are referred to the Office of Pediatric Therapeutics for one year after a labeling change; and (3) contract with the Institute of Medicine to study and report to Congress regarding the pediatric studies conducted pursuant to FFDCA since 1997.

Requires the Comptroller General to report to Congress on the effectiveness of FFDCA provisions relating to pediatric studies in ensuring that medicines used by children are tested and properly labeled.

]]> Pediatric Research Improvement Act Official Title as Introduced A bill to improve pediatric research. Introduced in Senate IS Display Title Pediatric Research Improvement Act Short Titles as Introduced Pediatric Research Improvement Act Introduced in Senate 2007-03-27T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s993is/xml/BILLS-110s993is.xml 2007-03-27 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.