News & Analysis as of

National Security Food and Drug Administration (FDA)

Hogan Lovells

FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

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The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more

Katten Muchin Rosenman LLP

FDA Scrutinizes Clinical Trials Exporting U.S. Genetic Material

On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Commissioner Launches Pilot Program To Speed Review of Certain Drugs

On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV). The program is intended...more

Sheppard Mullin Richter & Hampton LLP

Onshoring Pharma Ops: Reading Recent EO and Policy Tea Leaves

Recently, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate communications that aim to bolster domestic drug manufacturing while tightening oversight of...more

King & Spalding

New Executive Order Promotes Domestic Production of Critical Medicines

King & Spalding on

On May 5, 2025, President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of Critical Medicines. The EO directs the U.S. Food and Drug Administration (“FDA”), U.S....more

Morgan Lewis

From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO

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The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more

Hogan Lovells

Reshoring EO aims to streamline permitting, approval, and oversight of US drug manufacturing

Hogan Lovells on

On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more

Morgan Lewis - As Prescribed

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more

Foley Hoag LLP

U.S. Department of Commerce Investigates Possible Tariffs on Pharmaceuticals: Forecasting the Impact and an Opportunity to Comment

Foley Hoag LLP on

I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more

Clark Hill PLC

The Learned Concierge - March 2025, Vol. 17

Clark Hill PLC on

The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

Akin Gump Strauss Hauer & Feld LLP

Security Requirements and Compliance Obligations in DOJ's Final Rule on Data Transactions

The Department of Justice’s (DOJ) final rule implements President Biden’s Executive Order 14117 of February 28, 2024, on “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data...more

WilmerHale

BIS Increases Export Controls on Key Biotech Equipment

WilmerHale on

On January 15, 2025, BIS issued an Interim Final Rule that amends the Export Administration Regulation (EAR) to address dual use export control concerns about biotechnology. ...more

Sheppard Mullin Richter & Hampton LLP

Healthy AI: 2024 Year in Review

On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - September/October 2024

Welcome to the Akin Intelligence September-October recap. Around the one-year anniversary of the AI Executive Order, the White House announced that agencies had carried out their directives. Members of Congress introduced a...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 7, August 2024

Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business. ...more

Wiley Rein LLP

FCC Continues Push to Establish IoT Cyber Trust Mark Program

Wiley Rein LLP on

On February 22, 2024, the Federal Communications Commission (FCC or “Commission”) released a Public Draft of a Report and Order that, if adopted, would establish a voluntary labeling program for Internet of Things (IoT)...more

Braumiller Law Group, PLLC

Hot Topics in International Trade - August 2023 - Voluntary Disclosures of Export Violations: Understanding the Consequences

The realm of international trade and commerce operates under a complicated system of export control regimes that are designed to protect national security, curb the proliferation of sensitive technologies, and ensure strict...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Dorsey & Whitney LLP

U.S. National Security Issues in Cross-Border Food, Beverage & Agribusiness Deals

Dorsey & Whitney LLP on

On October 28, 2021, a bipartisan group of U.S. Senators introduced the Food Security is National Security Act of 2021 (the “Act”). Among other things, the Act would require the Committee on Foreign Investment in the United...more

Skadden, Arps, Slate, Meagher & Flom LLP

CARES Act Provides Much-Needed Stimulus for U.S. Businesses, Individuals

On March 27, 2020, Congress approved the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide financial assistance to individuals and businesses, which in aggregate greatly exceeds the financial package...more

Morgan Lewis

The Next Big Things: Insights for 2020

Morgan Lewis on

Autonomous cars, sports betting, and CBD products have burst onto the scene, setting the stage for major developments in how companies do business and how regulators monitor new innovations....more

Jones Day

Jones Day Global Privacy & Cybersecurity Update | Vol. 24

Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Submits Comment on the Preliminary Draft for the NIST Privacy Framework - On October 24, 2019, the Federal Trade Commission ("FTC") announced that...more

Jones Day

Jones Day Global Privacy & Cybersecurity Update | Vol. 23

Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - NIST Produces Roadmap for Improving Critical Infrastructure Cybersecurity Version 1.1 - On April 25, the National Institute of Standards and Technology...more

Morgan Lewis

Drugs and Other FDA-Regulated Products Among Latest Proposed Tariffs

Morgan Lewis on

The Trump administration has issued a fourth set of proposed tariffs on an additional $300 billion of goods related to China, this time adding a range of commercial goods across industries. This round affects medical devices...more

Jones Day

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 3

Jones Day on

FDA Amends Waivers to Sanitary Transportation Rule - On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more

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