US S4348

Bill

Prescription Drug User Fee Amendments of 2022 Medical Device User Fee Amendments of 2022 Biosimilar User Fee Amendments of 2022 Food and Drug Administration Safety and Landmark Advancements Act of 2022 Modernization of Cosmetics Regulation Act of 2022 Verifying Accurate Leading-edge IVCT Development Act of 2022 Generic Drug User Fee Amendments of 2022 VALID Act of 2022

Introduced
05/26/2022

In Committee
06/14/2022

Crossed Over

Passed

Dead
01/03/2023

Introduced Session

117th Congress

Bill Summary

A BILL To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar bio- logical products, and for other purposes.

Committee Categories

Health and Social Services

Sponsors (2)

Patty Murray (D)*, Richard Burr (R),

Last Action

Placed on Senate Legislative Calendar under General Orders. Calendar No. 444. (on 07/13/2022)

Official Document

https://www.congress.gov/bill/117th-congress/senate-bill/4348/all-info

(15 Companion Bills)

Version:

Document Type	Source Location
State Bill Page	https://www.congress.gov/bill/117th-congress/senate-bill/4348/all-info
BillText	https://www.congress.gov/117/bills/s4348/BILLS-117s4348rs.pdf
Bill	https://www.congress.gov/117/bills/s4348/BILLS-117s4348rs.pdf.pdf
BillText	https://www.congress.gov/117/bills/s4348/BILLS-117s4348is.pdf
Bill	https://www.congress.gov/117/bills/s4348/BILLS-117s4348is.pdf.pdf

Bill	Bill Name	Last Action	Type
HR7035	Biologics Market Transparency Act of 2022	Referred to the Subcommittee on Health.	Related
HR7640	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").	Referred to the House Committee on Energy and Commerce.	Related
HR7658	To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.	Referred to the House Committee on Energy and Commerce.	Related
HR7679	To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.	Referred to the House Committee on Energy and Commerce.	Related
HR9329	Small Business Establishment Registration Waiver Act	Referred to the Subcommittee on Health.	Related
S2628	Better ODDS To Reduce Diversion Act of 2021 Better Options for Drug Disposal Systems To Reduce Diversion Act of 2021	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S2952	FDA Modernization Act of 2021	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S4152	A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S4288	Reducing Animal Testing Act	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S4302	Biologics Market Transparency Act of 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2709)	Related
S4303	Interchangeable Biologics Clarity Act	Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2709-2710)	Related
S4378	Hatch-Waxman Improvement Act of 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S4446	Modernizing the Accelerated Approval Pathway Act of 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078)	Related
S4535	FDASRA Act of 2022 Food and Drug Administration Simple Reauthorization Act of 2022 Biosimilar User Fee Amendments of 2022 Generic Drug User Fee Amendments of 2022 Medical Device User Fee Amendments of 2022 Prescription Drug User Fee Amendments of 2022	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.	Related
S5002	FDA Modernization Act 2.0	Held at the desk.	Related

Bill

Bill Name

Last Action

Type

HR7035

Biologics Market Transparency Act of 2022

Referred to the Subcommittee on Health.

HR7640

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").

Referred to the House Committee on Energy and Commerce.

HR7658

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.

Referred to the House Committee on Energy and Commerce.

HR7679

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.

Referred to the House Committee on Energy and Commerce.

HR9329

Small Business Establishment Registration Waiver Act

Referred to the Subcommittee on Health.

S2628

Better ODDS To Reduce Diversion Act of 2021 Better Options for Drug Disposal Systems To Reduce Diversion Act of 2021

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

S2952

FDA Modernization Act of 2021

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

S4152

A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.

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

S4288

Reducing Animal Testing Act

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

S4302

Biologics Market Transparency Act of 2022

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2709)

S4303

Interchangeable Biologics Clarity Act

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2709-2710)

S4378

Hatch-Waxman Improvement Act of 2022

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

S4446

Modernizing the Accelerated Approval Pathway Act of 2022

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S3077-3078)

S4535

FDASRA Act of 2022 Food and Drug Administration Simple Reauthorization Act of 2022 Biosimilar User Fee Amendments of 2022 Generic Drug User Fee Amendments of 2022 Medical Device User Fee Amendments of 2022 Prescription Drug User Fee Amendments of 2022

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

S5002

FDA Modernization Act 2.0

Held at the desk.

Bill > S4348

summary

Introduced Session

Bill Summary

Committee Categories

Sponsors (2)

Last Action

Official Document

bill text

bill summary

bill summary

bill summary