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Administrative Procedure Act Medical Research

Dorsey & Whitney LLP

The Next Front in the Administration’s Sponsored Research Crackdown: What Recipients of Federal Funding - Particularly Grantees -...

Dorsey & Whitney LLP on

The Trump Administration’s effort to remake the Federal government’s relationship with Higher Ed and research grantees continues to gather steam, and an unprecedented recent letter to Harvard presages a potentially new front:...more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Dorsey & Whitney LLP

NIH’s New Unilateral Change to Your Institution’s Indirect Rate: An Old-School Breach of Contract?

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On Friday, February 7, the National Institutes of Health (“NIH”) issued Policy Statement Supplemental Guidance affecting budgets both for active grants and for future grants, which was set to take effect on Monday, February...more

Wiley Rein LLP

Capping It All Off: NIH Caps Indirect Rates for Grants

Wiley Rein LLP on

SUMMARY: On February 7, 2025, the Office of the Director for the National Institutes of Health (NIH) issued a Notice (Notice No. NOT-OD-25-068) imposing a cap of 15% on the indirect cost rates that can be charged to the...more

Troutman Pepper Locke

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper Locke on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

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