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Administrative Procedure Act Regulatory Reform Food and Drug Administration (FDA)

Clark Hill PLC

Administrative Law Report - April 2025, Vol. 6

Clark Hill PLC on

Welcome to your monthly rundown of all things administrative law, where we highlight all the happenings you may have missed. ...more

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

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The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

Knobbe Martens

District Court Finds the FDA Reasonably De-listed Eli Lilly’s Weight Loss Drug From Drug Shortage List

Knobbe Martens on

Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage. For example, a determination of...more

Epstein Becker & Green

HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

On March 3, 2025, the Secretary of Health and Human Services published a policy statement in the Federal Register that reverses a policy adopted over 50 years ago that was intended to expand public participation in the...more

Latham & Watkins LLP

HHS Issues Policy Statement to Expand Use of Rulemaking Without Notice and Comment

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The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

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