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Rulemaking Process › Food and Drug Administration (FDA) › Administrative Procedure Act

Mayer Brown

In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

Mayer Brown on

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

Carlton Fields

FDA v. Wages and White Lion Investments: A Reminder of the Deference to Agency Determinations Post-Loper Bright

Carlton Fields on

In FDA v. Wages and White Lion Investments LLC, the U.S. Supreme Court’s unanimous decision in favor of the Food and Drug Administration serves as a reminder of the deference still accorded to regulatory agencies post-Loper...more

Epstein Becker & Green

HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

Epstein Becker & Green on

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

Latham & Watkins LLP on

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

Hogan Lovells

FDA Delays Effective Date for Final Healthy Rule

Hogan Lovells on

On February 25, 2025, the U.S. Food and Drug Administration (FDA) delayed the effective date for its final “Healthy” rule from February 25, 2025 to April 28, 20251. The delayed effective date is in line with President Trump’s...more

Troutman Pepper Locke

Federal Appellate Court Agrees that FDA Cannot Regulate “Premium Cigars”

Troutman Pepper Locke on

Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...more

Hogan Lovells

Trump Administration Freezes Regulations and Takes Other Actions Affecting Industry

Hogan Lovells on

Shortly after being sworn in on January 20, President Trump issued several actions, including issuing executive orders and instructions to agencies, that will affect the regulatory environment facing the food and agriculture...more

Venable LLP

Implications of Loper Bright for FDA-Regulated Products

Venable LLP on

Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more

McDermott Will & Schulte

Guidance on Guidance: DOJ Limits Use of Agency Guidance Documents in Civil Enforcement Cases

McDermott Will & Schulte on

In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more

McDermott Will & Emery

Supreme Court to Decide Important Administrative Law Issue

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On December 1, 2014, the United States Supreme Court will hear oral argument in a case that will have significant implications for federal regulatory agencies like the U.S. Food and Drug Administration (FDA) and the Alcohol...more

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