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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.
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.
Read the Full Bill
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
9Democrat Sponsors
9Republican Sponsors
0Unaffiliated Sponsors
0Total Number of Cosponsors
25Democrat Cosponsors
9Republican Cosponsors
13Unaffiliated Cosponsors
3Policy Area and Potential Impact of Bill S 5046
Primary Policy Focus
HealthAlternate 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.
Comments
Sponsors and Cosponsors of S 5046
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