Speeding Therapy Access Today Act of 2021

Summary

Speeding Therapy Access Today Act of 2021 This bill requires and authorizes various actions to accelerate the development of therapies for rare diseases. The Food and Drug Administration (FDA) shall establish the Intercenter Institute on Rare Diseases and Conditions. The institute shall (1) coordinate engagement with relevant stakeholders, (2) build the FDA's expertise in the review of medical products to treat rare diseases, (3) coordinate regulatory science initiatives related to rare diseases, (4) establish and implement a program to make recommendations to address challenges associated with developing medical products to treat rare diseases in an individual or in very small populations, (5) convene a stakeholder meeting to consider potential amendments to labels for medical products to treat rare diseases, and (6) establish and carry out a program to facilitate voluntary communication between the sponsors of such medical products and third-party payers (e.g., insurance companies). The bill also authorizes the FDA to make grants to assist in developing practices related to the development and production of individualized therapies or therapies to treat very small populations. The bill also establishes an advisory committee to advise the FDA on issues related to the development of therapies to treat rare diseases.

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Timeline

1. 10 March 2021

   Introduced

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

   Source: IntroReferral

2. 10 March 2021

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 10 March 2021 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 10 March 2021

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 10 March 2021

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 10 March 2021

  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. Klobuchar, Amy [D-MN] · D · Sponsor
• Sen. Wicker, Roger F. [R-MS] · R · Sponsor
• · sshr00 · Standing

Related records

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