News & Analysis as of

Supply Chain Pharmaceutical Industry

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

Carlton Fields on

On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

Akin Gump Strauss Hauer & Feld LLP

Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve (Trump...

The Executive Order aims to bolster the resilience of the United States’s pharmaceutical supply chain by stockpiling Active Pharmaceutical Ingredients (“APIs”) for critical medicines in the Strategic Active Pharmaceutical...more

BakerHostetler

FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more

Katten Muchin Rosenman LLP

Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security

On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Foley Hoag LLP on

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

Carlton Fields

Agency Actions, Trade Deals, and Other Initiatives to Further Executive Order Goals for the Pharma Industry

Carlton Fields on

The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more

Barnea Jaffa Lande & Co.

European Commission Tightens Law Enforcement on Pharmaceutical Cartels

In July 2025, the European Competition Commission imposed a EUR 489,000 fine on Alchem International Pvt. Ltd. and its Hong Kong subsidiary for their involvement in a pharmaceutical cartel involving the active ingredient used...more

Goodwin

European Biosimilar Updates - Formycon’s Ustekinumab and Alvotech’s Cetrolizumab Pegol

Goodwin on

On June 26, 2025, Formycon AG (“Formycon”) announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH (“Ratiopharm”) for the semi-exclusive commercialization of its Stelara biosimilar FYB202/Fymskina...more

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

BakerHostetler

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

BakerHostetler on

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

Hogan Lovells

Medicines shortages under the EU pharma law package

Hogan Lovells on

The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more

Hogan Lovells

UK and U.S. economic prosperity deal takes effect – Key takeaways

Hogan Lovells on

The Economic Prosperity Deal agreed between the UK and the U.S. sets out high level trade commitments and areas for further negotiation between the two countries. A series of implementing measures are described in Executive...more

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

ArentFox Schiff on

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...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

Ankura

Forensic Analytics in Pharmaceutical Fraud Investigations: Lessons from Recent Cases

Ankura on

The pharmaceutical industry faces escalating risks from sophisticated fraud schemes, including counterfeit drug distribution, billing irregularities, and corporate malfeasance. Forensic analytics—powered by AI and advanced...more

Dacheng

China Monthly Antitrust Update: June 2025

Dacheng on

This monthly report outlines key developments in China’s antitrust sector for June. The following events merit special attention: SAMR Seeks Comments on Provisions for Curbing Acts of Abusing Administrative Power to Eliminate...more

Holland & Knight LLP

U.S. Pharmaceutical Manufacturing and Supply Chain: 2025 Risks, Opportunities for Stakeholders

Holland & Knight LLP on

The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more

Ankura

Reshaping Global Business Strategy: Where Will We Land on Tariffs

Ankura on

Dive into the world of global trade in the latest episode of The Impact Exchange with John Frehse as he is joined by trade expert Kate Kalutkiewicz!...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

Venable LLP

America First's First Trade Deal: White House Announces UK Deal "General Terms"

Venable LLP on

On May 8, the White House announced President Trump's first trade deal under his America First Policy. The deal struck between the United States and the United Kingdom will revise some of the tariffs imposed on the UK so far...more

Woodruff Sawyer

Cargo Stock Throughput Insurance for Life Science Companies

Woodruff Sawyer on

In the dynamic world of life sciences, companies face unique challenges in safeguarding their valuable assets. From pharmaceuticals to biologics, medical devices to vaccines, these products often require specialized handling...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

McGuireWoods LLP

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

McGuireWoods LLP on

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

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