Strengthening of FDA Integrity Act of 2009

Summary

Strengthening of FDA Integrity Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product. Requires the Secretary of Health and Human Services (HHS), in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available. Requires the Secretary to annually report to Congress on the implementation of debarment provisions.

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Timeline

1. 27 October 2009

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 27 October 2009

   Introduced

   Introduced in House

   Source: IntroReferral

3. 27 October 2009

   Introduced

   Introduced in House

   Source: IntroReferral

4. 28 October 2009

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 27 October 2009 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 27 October 2009

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 27 October 2009

  ViewDownloadOpen at official source

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  Vertaal document

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• Introduced in House

  summary · EN · 27 October 2009

  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

• Rep. Barton, Joe [R-TX-6] · R · Sponsor
• Rep. Shimkus, John [R-IL-15] · R · Sponsor
• Rep. Bono, Mary [R-CA-44] · R · Sponsor
• Rep. Terry, Lee [R-NE-2] · R · Sponsor
• Rep. Sullivan, John [R-OK-1] · R · Sponsor
• Rep. Burgess, Michael C. [R-TX-26] · R · Sponsor
• Sen. Blackburn, Marsha [R-TN] · R · Sponsor
• Rep. Walden, Greg [R-OR-2] · R · Sponsor
• · hsif00 · Standing

Related records

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