Surrogate Endpoint Improvement and Utilization Act of 2015

Hozzl · 2023-01-11T13:31:17Z

Explore the details of House Bill 2547 Surrogate Endpoint Improvement and Utilization Act of 2015 currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

1/11/2023, 1:31 PM

Congressional Summary of HR 2547

Surrogate Endpoint Improvement and Utilization Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the sponsor of a drug that is eligible for accelerated approval to request that the Food and Drug Administration (FDA) agree to an accelerated approval development plan that includes a surrogate endpoint for the study of the drug and a magnitude of drug effect that is sufficient to claim the drug is effective. (Accelerated approval is an FDA process for approving a new drug for a serious medical condition at a point in the study of the drug that is reasonably likely to predict a clinical benefit instead of at a later point when a clinical benefit can be confirmed.)

The FDA may require the sponsor to modify or terminate an agreed upon plan if additional information indicates that the plan is no longer sufficient to demonstrate the safety and effectiveness of the drug or the drug is no longer eligible for accelerated approval.

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Current Status of Bill HR 2547

Bill HR 2547 is currently in the status of Bill Introduced since May 21, 2015. Bill HR 2547 was introduced during Congress 114 and was introduced to the House on May 21, 2015. Bill HR 2547's most recent activity was Referred to the Subcommittee on Health. as of May 22, 2015

Bipartisan Support of Bill HR 2547

Total Number of Sponsors

Democrat Sponsors

Republican Sponsors

Unaffiliated Sponsors

Total Number of Cosponsors

Democrat Cosponsors

Republican Cosponsors

Unaffiliated Cosponsors

Policy Area and Potential Impact of Bill HR 2547

Primary Policy Focus

Health

Potential Impact Areas

Drug safety, medical device, and laboratory regulation

Alternate Title(s) of Bill HR 2547

Surrogate Endpoint Improvement and Utilization Act of 2015To amend the Federal Food, Drug, and Cosmetic Act to provide for the development of accelerated approval development plans for investigational drugs and biological products.Surrogate Endpoint Improvement and Utilization Act of 2015

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Comments

Sponsors and Cosponsors of HR 2547

Cathy McMorris Rodgers

Washington(Republican)

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