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Imports Pharmaceutical Industry

Benesch

Sectoral Tariff Update - Section 232 National Security Investigations

Benesch on

Sectoral tariffs are emerging as a preferred tool for the White House that leaves targeted industries, and those reliant on their import supply, subject to appreciably higher customs duties on imported goods. A wide range of...more

Husch Blackwell LLP

The US and EU Reach A Trade Deal—EU Goods Subject to 15% Tariff

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On July 27, 2025, President Trump announced that the U.S. and European Union (“EU”) have reached a trade deal. Pursuant to the Fact Sheet released by the White House on July 28th, the U.S. will impose a 15% tariff on all EU...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

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Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

Alston & Bird

Renewed Trade Offensive Continues: White House Announces 50% Tariffs on Copper, Previews Duties on Pharma and Chips

Alston & Bird on

Section 232 Investigation Ends with 50% Duties on Copper - On Tuesday, July 8, President Trump told reporters that he would soon announce a 50% tariff on copper—the result of a Section 232 Investigation into U.S. copper...more

Husch Blackwell LLP

Week Twenty-Four in Trade

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President Trump Announces Higher Tariff Rates Effective August 1st- After announcing an extension of the reciprocal tariff rates from July 9, 2025, to August 1,2025, President Trump published letters which were sent to...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

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In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Policy Shifts

BakerHostetler on

Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

Latham & Watkins LLP on

President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Braumiller Law Group, PLLC

Hot Topics in International Trade - June 2025 - Trump’s Plan B for Tariffs

On May 28, 2025, the United States’ Court of International Trade (CIT) struck down the President’s use of the International Economic Emergency Powers Act (IEEPA) to impose tariffs. This includes tariffs imposed on Canada,...more

Arnall Golden Gregory LLP

[Webinar] Mitigating the Impact of Tariffs: A Practical Guide for Life Sciences Companies - June 17th, 12:00 pm - 1:00 pm EDT

AGG partner and Life Science team member, Allison Raley, will present a complimentary webinar examining how life sciences companies can overcome challenges in the face of U.S. tariffs. As international trade tensions persist...more

A&O Shearman

UK will permanently retain its UK+ exhaustion regime to allow continued supply of medicines into the UK

A&O Shearman on

The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more

McGuireWoods LLP

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

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On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more

Polsinelli

Trump Administration Announces New Executive Order to Promote Domestic Production of Biopharmaceuticals

Polsinelli on

Key Takeaways - Regulatory Relief for U.S. Manufacturing: The EO streamlines FDA and EPA processes to encourage domestic pharmaceutical production....more

Akin Gump Strauss Hauer & Feld LLP

The Trump Administration Continues Focus on Drug Pricing with “Most-Favored-Nation Prescription Drug Pricing” Executive Order

On Monday, May 12, President Donald Trump signed an Executive Order (EO) titled, “Delivering Most-Favored-Nation Prescription Drug Pricing to Americans,” aimed at reducing prescription drug prices by implementing a...more

Holland & Knight LLP

Trump Administration Revives Most-Favored-Nation Drug Pricing: Here's What to Know

Holland & Knight LLP on

President Donald Trump on May 12, 2025, issued an executive order (EO) titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients" and an accompanying Fact Sheet, "President Donald J. Trump...more

Cooley LLP

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

Cooley LLP on

On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...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

Morgan Lewis

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

Morgan Lewis on

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

Pillsbury Winthrop Shaw Pittman LLP

President Trump Initiates Section 232 Investigations into Pharmaceuticals, Semiconductors, Critical Minerals and Trucks

The Trump administration has intensified its America First Trade Policy initiatives by announcing three new investigations under Section 232 of the Trade Expansion Act of 1962 by the Department of Commerce. As foreshadowed in...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

Orrick, Herrington & Sutcliffe LLP

Tariffs Loom for Imports of Semiconductor and Pharmaceutical Products and Critical Minerals as Trump Administration Initiates...

The Trump administration is pursuing additional national security investigations that will likely lead to tariffs on imports of semiconductors, semiconductor manufacturing equipment (“SME”), and derivative articles,...more

Kelley Drye & Warren LLP

New Section 232 Investigations Announced on Semiconductors, Pharmaceuticals, and Critical Minerals

Over the past few weeks, the Trump Administration has announced three new investigations under Section 232 of the Trade Expansion Act of 1962 into whether imports of pharmaceuticals, semiconductors, and critical minerals and...more

Fish & Richardson

Trump’s Drug Price Executive Order: What Drugmakers Should Know

Fish & Richardson on

On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...more

ArentFox Schiff

232 Investigation of Pharmaceuticals: Potential Tariffs and Tight Comment Deadline

ArentFox Schiff on

Effective April 5, the United States imposed a 10% baseline tariff on imports from nearly all countries, excluding products from Canada and Mexico, and those products contained in the Harmonized Tariff Schedule of the United...more

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