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Final Rules › FDA Approval

Akin Gump Strauss Hauer & Feld LLP

FDA Grants Three Natural Food Additive Petitions

Akin Gump Strauss Hauer & Feld LLP on

On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Troutman Pepper Locke

FDA Says Agency Will Enforce the Cigarette Graphic Warning Rule in December 2025, But Pending Litigation Could Still Derail Those...

Troutman Pepper Locke on

In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance...more

Foley Hoag LLP - Medicaid and the Law

CMS Weighs in on FDA Importation Rule

Foley Hoag LLP - Medicaid and the Law on

On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more

ArentFox Schiff

FDA Proposes to Revise “Intended Use” Regulations (Again) to Clarify that Knowledge Alone Is Not Sufficient to Establish Intent

ArentFox Schiff on

Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a...more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

Wilson Sonsini Goodrich & Rosati on

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

King & Spalding

International Food Law Gazette - January 2016

King & Spalding on

FDA Approves First Genetically Modified Food-Producing Animal - On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of...more

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