FDASLA Act of 2022

Summary

Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 This bill modifies Food and Drug Administration (FDA) authority to collect certain fees. It also expands FDA authority to regulate certain products, including cosmetics. Among other provisions, the bill reauthorizes FDA authority to collect certain fees related to drugs, medical devices, and biosimilar biological products and modifies such fees, including the base fee amounts; establishes that certain requirements related to obtaining market approval for a new drug or a biosimilar may be satisfied using alternatives to animal testing, such as in vitro tests; authorizes the FDA to require that certain drugs be dispensed with a safe disposal system even if the system does not render a drug nonretrievable (current law requires such a system to render the drug nonretrievable); establishes time lines for the FDA to respond to requests to determine whether a drug is a therapeutic equivalent to an approved drug; modifies the accelerated process for approving products for a serious or life-threatening disease or condition and establishes an intra-agency coordinating council to ensure consistent and appropriate use of the process; requires additional regulation of cosmetics, including by requiring manufacturers to register manufacturing facilities and each cosmetic product with the FDA; requires dietary supplement manufacturers to provide to the FDA certain information, including a list of all ingredients, about each dietary supplement that it markets; and requires an in vitro clinical test to receive FDA premarket approval or a technology certification (or be otherwise exempted) before being introduced into interstate commerce.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 26 May 2022

   Introduced

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

   Source: IntroReferral

2. 26 May 2022

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 14 June 2022

   Reported

   Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

   Source: Committee

4. 13 July 2022

   Calendars

   Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.

   Source: Calendars

5. 13 July 2022

   Reported

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.

   Source: Committee

6. 13 July 2022

   Reported

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Reported to Senate · 13 July 2022 · Download file
• Introduced in Senate · 26 May 2022 · Download file

Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 13 July 2022

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• Reported to Senate (PDF)

  Reported to Senate · EN · 13 July 2022

  ViewDownloadOpen at official source

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• Reported to Senate

  summary · EN · 13 July 2022

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  Vertaal document

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• Introduced in Senate (text)

  Introduced in Senate · EN · 26 May 2022

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  Vertaal document

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

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 26 May 2022

  ViewDownloadOpen at official source

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  Vertaal document

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

• Introduced in Senate

  summary · EN · 26 May 2022

  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. Murray, Patty [D-WA] · D · Sponsor
• Sen. Burr, Richard [R-NC] · R · Sponsor
• · sshr00 · Standing

Related records

• related to → Reducing Animal Testing Act
• related to → Biologics Market Transparency Act of 2022
• related to → To amend the Orphan Drug Act to reauthorize a program of grants and contracts for the development of drugs for rare diseases and conditions (commonly referred to as "orphan drugs").
• related to → To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
• related to → To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.
• related to → Better ODDS To Reduce Diversion Act of 2021
• related to → FDA Modernization Act of 2021
• related to → A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
• related to ← Hatch-Waxman Improvement Act of 2022
• related to ← Modernizing the Accelerated Approval Pathway Act of 2022
• related to ← FDASRA Act of 2022
• related to ← FDA Modernization Act 2.0
• related to ← Small Business Establishment Registration Waiver Act

Showing 13 of 15 related records.