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Manufacturers › Imports › New Regulations

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

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

Bracewell LLP

The Carbon Border Adjustment Mechanism: How to Navigate a Complex Mechanism

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This note is dedicated to importers and producers of specific goods from countries outside the European Union, who will be subject to carbon pricing equivalent to that applied to European manufacturers of the same goods,...more

Cozen O'Connor

EPA Revises PFAS Reporting Timeline to Begin April 13, 2026

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The EPA has announced an interim final rule adjusting the PFAS reporting requirements under the Toxic Substances Control Act (TSCA). The new reporting period will commence on April 13, 2026, and conclude on October 13, 2026....more

Mayer Brown

Brazil Introduces Regulations on the Importation of Solid Waste and Tailings

Mayer Brown on

The Brazilian government published Decree No. 12,451/2025 (the “New Decree”), which regulates Article 49, §1 of the National Solid Waste Policy (Law No. 12,305/2010), establishing exceptions to the ban on importing solid...more

Arnall Golden Gregory LLP

Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

Arnall Golden Gregory LLP on

In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

Hogan Lovells on

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

Husch Blackwell LLP

Amendments to Tariffs on Imports of Automobiles and Automobile Parts

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On April 29, 2025, President Trump issued a Proclamation (the “Proclamation”) amending the tariffs applicable to imports of automobiles and automobile parts. The Proclamation issued on April 29th, amends Proclamation 10908...more

McDermott Will & Schulte

European SPC Manufacturing Waiver Goes into Force

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Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

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