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Imports Food and Drug Administration (FDA) Customs and Border Protection

Troutman Pepper

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

Troutman Pepper on

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

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

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

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

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

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - March 2018

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

FDA Announces Import Staffing Change at International Mail Facilities

Earlier this month, The Washington Post reported that Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that he was reallocating three dozen employees to international mail facilities (IMF), as well as...more

Jones Day

FDA Issues Further Guidance Related to FSVP

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On May 11, 2017, FDA announced a new updated fact sheet and a guidance related to the use of a Unique Facility Identifier that is acceptable under the Foreign Supplier Verification Program ("FSVP") regulation. The three-page...more

Faegre Drinker Biddle & Reath LLP

Food and Drug Administration Attempts to Streamline Review of Imports

The Food and Drug Administration (FDA) issued a final rule on November 29, 2016, establishing requirements for the electronic filing of import entries of FDA-regulated products. Once the rule takes effect, the entries must be...more

Arnall Golden Gregory LLP

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

King & Spalding

U.S. Customs And Border Protection Announces Three New Members Of Commercial Targeting And Analysis Center

King & Spalding on

Participating agencies jointly target commercial imports that threaten health and safety - U.S. Customs and Border Protection (CBP) announced on April 1 that three additional Federal agencies have formally joined the...more

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