To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes.

Summary

This bill requires the Food and Drug Administration (FDA) to continue to review applications for certain biological products under an earlier review process, notwithstanding recent FDA guidance. Specifically, the bill applies to applications that were filed under the earlier process on or before March 23, 2019, and were still pending on March 23, 2020. (A 2009 law established a new procedure for approving biological products but allowed certain products in an already approved product class to receive approval under the earlier procedure until March 23, 2020; subsequently, in December 2018, the FDA issued guidance stating that an application filed under the earlier procedure that is not approved by March, 23, 2020, will not be approved.)

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Timeline

1. 9 March 2020

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 9 March 2020

   Introduced

   Introduced in House

   Source: IntroReferral

3. 9 March 2020

   Introduced

   Introduced in House

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in House · 9 March 2020 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 9 March 2020

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 9 March 2020

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 9 March 2020

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  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. Grothman, Glenn [R-WI-6] · R · Sponsor
• · hsif00 · Standing

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