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Federal Advocacy

Stay updated on federal initiatives and policies influencing the bio-industry across the country. This category highlights national-level advocacy efforts, initiatives, and developments driving innovation and growth across the industry.

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SBIR/STTR Reauthorization Advances to President's Desk
Posted In: Federal Advocacy,
Date posted Mar 20

The future of the SBIR/STTR programs has been a critical issue for the life sciences innovation ecosystem, as highlighted in prior biolink...

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FDA Signals Shift Toward Human-Based Drug Testing as NIH Commits to $150M to Alternatives
Posted In: Federal Advocacy,
Date posted Mar 20

The U.S. drug development landscape is entering a pivotal transition, as federal regulators and research funders accelerate efforts to reduce...

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EPA Moves to Rescind Biden-Era Ethylene Oxide Limits, Reigniting Debate Over Safety and Supply Chain
Posted In: Federal Advocacy,
Date posted Mar 20

A new proposal from the U.S. Environmental Protection Agency (EPA) is reshaping the regulatory landscape for medical device sterilization -...

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FDA Guidance Links Study Design to 3-Year Exclusivity
Posted In: Federal Advocacy,
Date posted Mar 20

The FDA’s recent draft guidance clarifying the scope of 3-year New Clinical Investigation (NCI) exclusivity is more than a technical update...

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New Federal Legislation Targets "AI-ready" Biological Data to Accelerate Drug Development
Posted In: Federal Advocacy,
Date posted Mar 20

A bipartisan group of lawmakers has introduced new legislation aimed at tackling a foundational challenge in AI-driven drug discovery - the lack...

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U.S. Senate Advances SBIR/STTR Reauthorization, Restoring a Critical Innovation Pipeline
Posted In: Federal Advocacy,
Date posted Mar 6

After months of uncertainty for startups and technology innovators across the country, the U.S. Senate has passed bipartisan legislation, S....

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House Biotech Caucus Endorses Key Biotechnology and Biomanufacturing Legislation
Posted In: Federal Advocacy,
Date posted Mar 6

The bipartisan House BIOtech Caucus recently announced its first-ever legislative endorsements, backing two bills aimed at strengthening U.S....

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Codifying MFN Drug Pricing Could Undermine Biopharma Innovation
Posted In: Federal Advocacy,
Date posted Feb 20

As Congress considers whether to codify Most Favored Nation (MFN) drug pricing into statute, recent comments by CMS Administrator Dr. Mehmet Oz...

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FDA to Adopt Single-trial Default Policy: Implications for Biopharma and Vaccine Innovation
Posted In: Federal Advocacy,
Date posted Feb 20

The U.S. Food and Drug Administration (FDA) has announced a significant shift in its drug approval standards, moving away from the long-standing...

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How NIH’s New Funding Philosophy Shapes Innovation & U.S. Competitiveness
Posted In: Federal Advocacy,
Date posted Feb 6

The January 30, 2026 announcement of a Unified NIH Funding Strategy marks one of the most consequential shifts in federal biomedical research...

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More NIH: Director Rebuts Accusations of Grant Cancellations and Clinical-trial Disruptions
Posted In: Federal Advocacy,
Date posted Feb 6

National Institutes of Health (NIH) Director Dr. Jayanta “Jay” Bhattacharya faced a pointed round of bipartisan scrutiny at a Senate...

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Congress Advances Rare Disease & Cancer Innovation
Posted In: Federal Advocacy,
Date posted Feb 6

In overlapping victories for biotech innovation and public health, the U.S. Senate and House of Representatives have approved two landmark pieces...

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