Pediatric Research Improvement Act

Summary

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.

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Timeline

1. 27 March 2007

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 27 March 2007

   Introduced

   Sponsor introductory remarks on measure. (CR S3842)

   Source: IntroReferral

3. 27 March 2007

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 27 March 2007 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 27 March 2007

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 27 March 2007

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 27 March 2007

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Clinton, Hillary Rodham [D-NY] · D · Sponsor
• Sen. Dodd, Christopher J. [D-CT] · D · Sponsor
• · sshr00 · Standing

Related records

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