Increasing Transparency in Generic Drug Applications Act

Summary

Increasing Transparency in Generic Drug Applications Act This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.

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Timeline

1. 14 March 2023

   Introduced

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

   Source: IntroReferral

2. 14 March 2023

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 14 March 2023 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 14 March 2023

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 14 March 2023

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 14 March 2023

  Open at official source

Sponsors

• Maggie Hassan · D · Sponsor
• Rand Paul · R · Sponsor
• Sen. Braun, Mike [R-IN] · R · Cosponsor
• John Hickenlooper · D · Cosponsor
• · sshr00 · Standing

Related records

• related to ← Expanding Access to Low-Cost Generics Act of 2023
• related to ← PATIENT Act of 2023
• related to ← To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
• related to ← Lower Costs, More Transparency Act
• related to ← Increasing Transparency in Generic Drug Applications Act