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Office of Management and Budget OIRA Food and Drug Administration (FDA)

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Goodwin

FDA’s Laboratory Developed Test (LDT) Final Rule Under OIRA Review

Goodwin on

On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory...more

Epstein Becker & Green

Making Moves – FDA’s LDT Proposed Rule Sent to OMB for Review

As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of...more

Hogan Lovells

OMB Issues Memorandum Guidance on Executive Departments’ and Agencies’ Compliance with the Congressional Review Act

Hogan Lovells on

The Office of Management and Budget (OMB) recently issued an updated memorandum to the heads of executive departments and agencies entitled, “Guidance on Compliance with the Congressional Review Act” (2019 Memo). The 2019...more

Hogan Lovells

New OMB review process could impede FDA issuance of guidance documents

Hogan Lovells on

Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents. ...more

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