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FDA Modernization Act 3.0

1/14/2025, 7:02 PM

Summary of Bill S 5046

Bill 118 s 5046, also known as the FDA Modernization Act 3.0, is a piece of legislation currently being considered by the US Congress. The main goal of this bill is to modernize and improve the operations of the Food and Drug Administration (FDA), which is responsible for regulating food, drugs, medical devices, and other products to ensure they are safe and effective for consumers.

Some key provisions of the FDA Modernization Act 3.0 include:

1. Strengthening the FDA's ability to regulate new technologies, such as digital health products and personalized medicine, by providing additional resources and expertise. 2. Improving the FDA's ability to respond to public health emergencies, such as outbreaks of foodborne illness or the spread of infectious diseases, by streamlining the agency's processes and increasing coordination with other government agencies. 3. Enhancing the FDA's ability to monitor and address safety concerns related to prescription drugs and medical devices, including implementing new measures to track adverse events and improve post-market surveillance. 4. Promoting innovation in the development of new medical products by providing incentives for research and development, streamlining the approval process for certain products, and encouraging collaboration between the FDA and industry stakeholders. Overall, the FDA Modernization Act 3.0 aims to ensure that the FDA is equipped to effectively regulate the rapidly evolving landscape of food and drug products in order to protect public health and promote innovation in the healthcare industry.

Congressional Summary of S 5046

FDA Modernization Act 3.0

This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug. 

The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications, and may make other changes to the regulations as appropriate. 

The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule. 

Current Status of Bill S 5046

Bill S 5046 is currently in the status of Passed in Senate since December 12, 2024. Bill S 5046 was introduced during Congress 118 and was introduced to the Senate on September 12, 2024.  Bill S 5046's most recent activity was Held at the desk. as of December 16, 2024

Bipartisan Support of Bill S 5046

Total Number of Sponsors
9
Democrat Sponsors
9
Republican Sponsors
0
Unaffiliated Sponsors
0
Total Number of Cosponsors
25
Democrat Cosponsors
9
Republican Cosponsors
13
Unaffiliated Cosponsors
3

Policy Area and Potential Impact of Bill S 5046

Primary Policy Focus

Health

Alternate Title(s) of Bill S 5046

FDA Modernization Act 3.0
FDA Modernization Act 3.0
A bill to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.

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