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Customs and Border Protection Food and Drug Administration (FDA)

Troutman Pepper

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

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In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

Rivkin Radler LLP

The Case of ‘Gas Station Heroin’

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Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more

Braumiller Law Group, PLLC

November 2023 Newsletter

In recent years, the global spotlight has illuminated the grave concerns surrounding human rights violations within China's Xinjiang region, particularly those impacting the Uyghur population. The Uyghur Forced Labor...more

Braumiller Law Group, PLLC

Hot Topics in International Trade - November 2023 - Any Comments on FDA’s New Proposed Rule on Prior Notice Regulations?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires the Food and Drug Administration (FDA) to take additional measures for safeguarding the public against potential terrorist attacks on...more

ArentFox Schiff

Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies

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Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more

Husch Blackwell LLP

Preparing for Impact of Government Shutdown on International Trade Functions

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As of Friday September 29, 2023, the United States Congress has yet to reach a spending agreement, as a result companies with international trade operations should prepare for a potential Federal government shutdown. The...more

Husch Blackwell LLP

MoCRA: Facility Registration and Product Listing – Where to Begin?

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Facility Registration: What Is a Facility and Who Has to Register? Section 607 of MoCRA requires the registration of facilities that manufacture or process cosmetics for distribution in the United States. While this...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

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As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

Tarter Krinsky & Drogin LLP

Voluntary Qualified Importer Program Opens For Fiscal Year 2022

The U.S. Food and Drug Administration (FDA) recently opened an application portal for a Voluntary Qualified Importer Program (VQIP) for fiscal year 2022. Through a voluntary, fee-based model, VQIP provides participating...more

Kelley Drye & Warren LLP

COVID-19 Washington Update: September 2020

Below, please find a summary of recent federal government activity in response to the COVID-19 pandemic. Congress - On Tuesday, after returning from the August recess, Senate Republicans unveiled a “targeted” COVID...more

Arnall Golden Gregory LLP

No Food for You: FDA Detention of Food

Maybe it’s a product that you’ve imported into the U.S. dozens of times. Maybe this is your first time importing this product or you’re working with a new business partner. Maybe you’re very familiar with the process, or...more

Arnall Golden Gregory LLP

A Funny Thing Happened on the Way to the Border: Avoidable Mistakes with FDA-Regulated Product Detentions

Al Stewart’s 1970s song, “On the Border,” comes to mind every so often when an existing or new client contacts us as their product is stopped at the United States border by the Food and Drug Administration. Lately, during...more

Kelley Drye & Warren LLP

COVID-19 Washington Update: July 2020 #7

Below, please find a summary of the federal government’s activities in response to COVID-19 since Friday’s update. Our next update will be published Wednesday, July 22....more

Kelley Drye & Warren LLP

COVID-19 Washington Update: July 2020 #1

Below, please find a summary of today’s federal government activities in response to COVID-19. Please note we will not be publishing updates for the remainder of the week due to the July 4th holiday. Our next update will be...more

Kelley Drye & Warren LLP

COVID-19 Washington Update: June 2020 #6

Below, please find a summary of the federal government’s response to the COVID-19 pandemic since our last update (Thursday, June 18) – including today’s proclamation by President Trump to extend and expand COVID-19 related...more

Kelley Drye & Warren LLP

COVID-19 Washington Update: May 2020 #8

Congress - The House returns to Washington this week, with plans to vote Thursday on two pieces of legislation related to the SBA’s small business lending programs....more

Foley Hoag LLP

COVID-19 Supply Chain and Trade Update #3

Foley Hoag LLP on

Foley Hoag’s Trade Sanctions & Export Controls Practice offers experienced, proactive regulatory advice to help clients avoid regulatory compliance missteps and to prevail in official proceedings. Included in this Issue: ...more

Eversheds Sutherland (US) LLP

Sending PPE in and out of the US

In response to shortages of Personal Protective Equipment (PPE) critical to limiting the spread of and mitigating the impact of COVID-19, the United States has recently issued a series of rules, memoranda, and other guidance...more

Foley Hoag LLP

COVID-19 Impacts on Trade, Export Controls, and Supply Chain

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Updates from March 11 to March 25, 2020 - Key Takeaways: Supply chain disruption has begun on some fronts that are not directly related to the healthcare and medical fields, and is anticipated to continue as the effects...more

ArentFox Schiff

The Importation of Personal Protective Equipment for Treatment of COVID-19

ArentFox Schiff on

News reports show that because of the spread of the novel coronavirus (COVID-19) pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the healthcare system. Masks, ventilators, and gowns are...more

Gibney Anthony & Flaherty, LLP

Online Safety: Avoiding Counterfeit COVID-19 Testing Kits

Almost as if on cue, as the United States ramps up testing and containment measures, US Customs and Border Protection (CBP) announced its first seizure of counterfeit COVID-19 test kits at the Los Angeles Airport...more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

Mintz - Health Care Viewpoints

Medical Products & FDA: What to Watch for in 2019

Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Russian

ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Chinese

ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more

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