News & Analysis as of

Bureau of Industry and Security (BIS) Pharmaceutical Industry

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

Fenwick & West LLP

The Continued Retreat: Commerce Secretary Announces Section 232 Investigations into Pharmaceuticals and Semiconductors

Fenwick & West LLP on

Section 232 investigations determine whether the targeted U.S. imports threaten to impair U.S. national security. At the conclusion of a Section 232 investigation (which can last for up to 270 days), the President must...more

Alston & Bird

Commerce Seeks Comments on Section 232 Pharmaceutical Investigation

Alston & Bird on

Yesterday, April 16, 2025, the Bureau of Industry and Security (BIS), a bureau within the U.S. Department of Commerce, published a “Notice of Request for Public Comments on Section 232 National Security Investigation of...more

White & Case LLP

Trump Administration Initiates Section 232 Investigations on Pharmaceuticals and Semiconductors

White & Case LLP on

On April 14, 2025, the US Department of Commerce Bureau of Industry and Security (BIS) announced the initiation of investigations into the effects on US national security of imports of pharmaceuticals and pharmaceutical...more

Goodwin

The BIOSECURE Act and Its Potential Implications

Goodwin on

Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more

The Volkov Law Group

Navigating Recent BIS Changes to the EAR: A Practical Primer for the Medical Device and Product Industry

The Volkov Law Group on

Among other things, on May 19, 2023, the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) issued a sweeping new set of restrictions that collectively operate to deter the Putin Regime from acquiring...more

Lowenstein Sandler LLP

Trade Matters - Lowenstein Sandler's Global Trade & Policy Newsletter - May 2021

Lowenstein Sandler LLP on

1. BIS Eliminates Reporting Requirements for Certain Encryption Items Effective March 29, 2021, BIS eliminated or reduced reporting requirements for certain encryption items. For encryption source code and beta test...more

Hogan Lovells

Proposed additions of chemical families to Schedule 1 of Chemical Weapons Convention and BIS requests for comments from chemical,...

Hogan Lovells on

On 14 August 2019 the U.S. Department of Commerce published a proposed change to the list of "Schedule 1" chemicals in the "Annex on Chemicals" to the Chemical Weapons Convention (CWC). ...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - September 2018

ANTICORRUPTION DEVELOPMENTS - Petrobras Settles with U.S. Authorities Over Alleged FCPA Violations - On September 27, 2018, the U.S. Department of Justice (DOJ) and the Securities and Exchange Commission (SEC)...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

Baker Donelson on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Hogan Lovells

The Obama Administration Eases Sanctions Against Sudan

Hogan Lovells on

On January 13, 2017, the White House, the U.S. Department of Treasury ’s Office of Foreign Assets Control (OFAC) , and the U.S. Department of Commerce ’s Bureau of Industry and Security (BIS) announced a host of policy...more

Skadden, Arps, Slate, Meagher & Flom LLP

"OFAC and BIS Implement Additional Amendments in Support of Cuba Policy Shift"

On October 14, 2016, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security (BIS) announced further amendments to ease U.S. sanctions and...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - October 2014

Welcome to the October 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. - This month on the anticorruption front, a Texas company agrees to pay more than $5 million to settle allegations...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - July 2014

Welcome to the July 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, two Noble Corporation executives settle with the U.S. Securities and Exchange...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsleter

Welcome to the May 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month, on the anticorruption front, Avon Products, Inc. (“Avon”) agrees to pay USD $135 million to settle a...more

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