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Executive Orders Federal Food Drug and Cosmetic Act (FFDCA)

Foley & Lardner LLP

DOJ Consumer Branch's End Leaves FDA Litigation Questions

Foley & Lardner LLP on

With the dissolution of the U.S. Department of Justice’s Consumer Protection Branch set to occur by Sept. 30, a vital question that remains to be fully answered is who will be responsible for litigation matters typically...more

Morgan Lewis

16 States Challenge Gender-Affirming Care EO as DOJ Scrutinizes Hospitals, Doctors, and Pharma Manufacturers

Morgan Lewis on

On August 1, 2025, 16 state attorneys general filed a complaint in federal court in Massachusetts against the US administration seeking a declaratory judgment that President Trump’s January 28, 2025 Executive Order 14187,...more

Morrison & Foerster LLP

FDA Targets 52 “Obsolete” Food Standards of Identity for Revocation

On July 17, 2025, FDA announced several rulemakings aimed at modernizing its standards of identity (SOIs) for food products – regulations that define what a food must contain and how it must be made to lawfully bear a...more

Latham & Watkins LLP

Key Insights on President Trump Executive Order Limiting Criminal Enforcement of Regulatory Offenses

Latham & Watkins LLP on

The executive order shifts policy on enforcement of criminal regulatory offenses, steering away from criminal enforcement of strict liability offenses in regulatory matters....more

Hogan Lovells

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

Hogan Lovells on

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

Hinch Newman LLP

DOJ Issues Rule Addressing Threat Posed by Foreign Adversaries’ Access to Americans’ Sensitive Personal Data

Hinch Newman LLP on

On Friday, December 27, 2024, the Justice Department issued a final rule to address “urgent national security risks posed by access to U.S. sensitive personal and government-related data from countries of concern and covered...more

Ropes & Gray LLP

DOJ Issues Notice of Proposed Rulemaking to Restrict Flow of Bulk Sensitive Personal Data to China and other Countries of Concern

Ropes & Gray LLP on

On October 29, 2024, the Department of Justice (“DOJ”) published its Notice of Proposed Rulemaking (“NPRM”) to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

King & Spalding

Trump Administration Continues to Promote Drug Importation as a Way to Lower the Cost of Prescription Drugs

King & Spalding on

On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more

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