News & Analysis as of

Manufacturers National Security

Arnall Golden Gregory LLP

“Back in the U.S.A.”: FDA Launches PreCheck Program to Boost Domestic Drug Manufacturing

Chuck Berry’s 1959 hit, “Back in the U.S.A.” came to mind as we reviewed the Food and Drug Administration’s recent move to bolster the resilience of the U.S. pharmaceutical supply chain by introducing the FDA PreCheck...more

Paul Hastings LLP

White House and DoD Unleash New Directives on Drones

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The White House and Department of Defense (DoD) have announced a series of new directives that will significantly impact the burgeoning domestic drone industry. This initiative, titled “Unleashing American Drone Dominance,”...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

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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

Bergeson & Campbell, P.C.

DOD Publishes 2025 Update on Critical PFAS Uses, Recommends Risk-Based Approach to Defining PFAS

The U.S. Department of Defense (DOD) has published a July 2025 report entitled Update on Critical Per- and Polyfluoroalkyl Substance Uses. House Report 118-121, which accompanied the 2024 DOD appropriations bill (H.R. 4365),...more

Akin Gump Strauss Hauer & Feld LLP

Regulatory Relief for Certain Stationary Sources to Promote American Iron Ore Processing Security (Trump EO Tracker)

Grants a two-year exemption from the EPA’s Taconite Rule to seven iron ore processing facilities operated by U.S. Steel and Cleveland-Cliffs. Extends all compliance deadlines under the rule, maintaining pre-existing emissions...more

Kelley Drye & Warren LLP

Commerce Department Announces New Section 232 Investigations on Polysilicon and its Derivative Products and Unmanned Aircraft...

On July 14, 2025, the Commerce Department announced new investigations initiated by the Secretary of Commerce on July 1, 2025, pursuant to Section 232 of the Trade Expansion Act of 1962. The pre-publication Federal Register...more

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

Wiley Rein LLP

ATF Allows Importation of Dual-Use Firearm Barrels, Irrespective of Previous Status or Configuration

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The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has issued Ruling 2025-1, which loosens ATF’s policy with respect to the importation of firearm barrels. Specifically, the agency will now allow the importation of...more

Womble Bond Dickinson

FCC Proposes to Add Certain Connected Vehicle Technologies to the Covered List

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The Federal Communications Commission’s (FCC or Commission) Public Safety and Homeland Security Bureau (Bureau) and Office of Engineering and Technology (OET) have published a Public Notice seeking input on adding certain...more

McGuireWoods LLP

Companies Moving Manufacturing to U.S. Must Be Careful of “Made in USA” Rule and Guidance

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The Trump administration declared “Made in America” to be “an economic and national security priority of this Administration” and has taken steps through tariffs and other means to encourage American manufacturing. Companies...more

Bergeson & Campbell, P.C.

EPA Receives TSCA Section 21 Petitions Seeking Reconsideration of Exemption Conditions in Final Trichloroethylene Rule

The U.S. Environmental Protection Agency (EPA) recently updated its website to include two petitions submitted under Section 21 of the Toxic Substances Control Act (TSCA) that seek reconsideration of exemption provisions of...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

Why medical device companies must prioritize compliance with DOJ's Data Security Program

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This regulation is designed to protect U.S. national security by restricting the transfer of bulk sensitive data to foreign entities associated with “countries of concern,” including China, Russia, Iran, North Korea, Cuba,...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Synthetic Organic Chemical Manufacturing Industry/Polymers and Resins Industry NESHAP: American Chemistry Council/American Fuel &...

The American Chemistry Council (“ACC”) and American Fuel & Petrochemical Manufacturers (“AFPM”) sent a March 31st letter to the United States Environmental Agency (“EPA”) requesting: …a two-year exemption from the...more

Holland & Knight LLP

Reframing Coal: Executive Order Aims to Power AI, Manufacturing and Energy Security

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President Donald Trump signed an executive order (EO), "Reinvigorating America’s Beautiful Clean Coal Industry and Amending Executive Order 1424," on April 8, 2025, that places coal at the center of the administration's...more

Fox Rothschild LLP

Driving Up Costs? Trump’s New 25% Tariff Hits Imported Cars and Parts

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The Trump administration has announced a 25% tariff on imported passenger vehicles and auto parts — on top of existing duties — potentially reshaping pricing, sourcing and production strategies across the auto industry. The...more

Hogan Lovells

How to leverage Advanced Purchase Agreements for military supply

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The EU is introducing new regulations (EDIRPA and EDIP) to structure military procurement through pooled orders coordinated by the European Commission. Advanced Purchase Agreements (APAs), inspired by COVID-19 contracts,...more

American Conference Institute (ACI)

[Event] 15th Forum on Global Encryption, AI, Cloud & Cyber Export Controls - March 26th - 27th, San Francisco, CA

As global trade policy evolves faster than ever, now is the time to connect with your peers, discover new strategies, and most importantly, hear from the regulatory agencies on the front lines of policy change. ACI’s 15th...more

Akin Gump Strauss Hauer & Feld LLP

Adjusting Imports of Aluminum into The United States (Trump EO Tracker)

As of March 12, 2025, this order: Terminates the alternative arrangements under Section 232 for exempt countries (Argentina, Australia, Mexico, Canada, the EU, and the UK)....more

Baker Donelson

Use of the Defense Production Act Title III Expected to Increase Under President Trump to Support U.S. Defense Industrial Base

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The Defense Production Act Title III (DPA Title III) was utilized during President Trump's first term to support certain materials critical to national defense and in response to the COVID-19 pandemic. President Biden...more

Hogan Lovells

U.S. BIS final rule prohibits imports, sales of connected vehicles and systems with China or Russia nexus

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On January 14, 2025, the U.S. Department of Commerce Bureau of Industry and Security (BIS) published the Final Rule addressing national security risks associated with connected vehicle technologies. The final rule, which...more

Ankura

Fueling Tech Growth: New Federal Financing from the Department of Defense’s Strategic Capital Program

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Growth companies needing to scale manufacturing capacity often struggle to source adequate and affordable financing. Traditional banks usually can not take the credit risk and non-bank lenders (e.g. private equity) impose...more

Brownstein Hyatt Farber Schreck

EXIM Launches Supply Chain Resiliency Initiative to Bolster U.S. Competitiveness

On Jan. 8, the Export-Import Bank of the United States (EXIM) announced the creation of the Supply Chain Resiliency Initiative (SCRI), a targeted financing program aimed at diversifying and strengthening critical mineral and...more

Sheppard Mullin Richter & Hampton LLP

The Persistence of (High Bandwidth) Memory: Semiconductor Manufacturing Equipment and Korean Semiconductor Manufactures Face...

On December 2, 2024, the Department of Commerce, Bureau of Industry and Security (BIS) issued a new set of regulations targeting semiconductors manufacturing equipment (SME) and high-bandwidth memory (HBM) chips. The updates...more

Blank Rome LLP

BIS Issues Significant New Round of Semiconductor Export Controls: Six Notable Changes

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The U.S. Department of Commerce, Bureau of Industry and Security (“BIS”) recently issued significant new export controls under the Export Administration Regulations (“EAR”) aimed at further restricting semiconductor...more

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