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Republicans Pass the One Big Beautiful Bill Act Ahead of the July 4 Deadline

On June 16, 2025, Senate Finance Committee Chairman Mike Crapo released text and a section-by-section summary of the Senate’s proposed One Big Beautiful Bill Act. The Senate passed a revised version of this measure on July 1,...more

Just Prior to Leadership Change, FDA Announces Public Workshops to Advance Dialogues on HCT Product Development and Optimizing...

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more

FDA Announces Draft Guidance on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more

A New Year, Congress and Trump Administration: 10 Health Issues to Watch in 2025

As the new year begins, change is afoot inside the Beltway as the 119th Congress gets underway and Washington prepares for President Trump’s second administration. While change is bringing uncertainty on some fronts, health...more

Lame Duck Agenda

With a historic election now behind us, the 118th Congress will return to work for a Lame Duck session to address must-pass items and for Senate Democrats to pass as many final judicial appointments as time and political will...more

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