Don’t Let FDA Target Your Medical Device Company

Did you know FDA has issued 1,569 enforcement actions against  medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.

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Insight on Last 6 Months of Biden/Congress on Trade

A lot has happened in the first 6 months of the Biden administration. Notable developments include (at least temporary) resolutions in the large civil aircraft and digital service tax disputes, consensus around a global minimum corporate tax of 15%, lawsuits pertaining to Section 232, increased export controls enforcement, shifting U.S. policy stances on Cuba, and more. However, the most important developments pertain to the ongoing U.S.-China trade war. The U.S. and China are engaged in ongoing negotiations while tensions have risen, a lawsuit challenging Trump’s imposition of 301 tariffs are underway, and a massive U.S. competitiveness bill is being considered in Congress that could bring back broad China tariff exclusions. Join us for a jam-packed hour where we discuss everything that has happened in the world of U.S. trade policy over the past 6 months, and provide insight into how Biden’s trade policies affect industry.

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Diaz Trade Law Invites the Trade Community to Two Free Webinars this Summer!

Celebrate the summer season with two light hearted webinars on International Trade. Diaz Trade Law invites the trade community to two FREE webinars; space is limited – register today! Laugh with us at the Humor in International Trade webinar and learn insightful facts about the impact of international trade on American history during The First Laws — History of Customs and Revenue Law. More information about each webinar is provided below:

Can We Find Humor in International Trade? – July 14, 2021 at 12:00 PM ET

This one-hour webinar describes humor in trade. International Trade is a serious subject, but within it, bits of humor can be found. Register today to hear from this experienced duo and discover many of the oddities and idiosyncrasies prevalent in our modern-day international trade system.

President and Founder of Diaz Trade Law, Jennifer (Jen) Diaz is a Chambers ranked, Board Certified International Attorney specializing in customs and international trade.

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Submitting Voluntary Self-Disclosures to Bureau of Industry & Security

Diaz Trade Law’s President, Jennifer Diaz,  and Associate Attorney, Sharath Patil, are enthusiastic to announce Bloomberg Law published another one of our articles, “Submitting Voluntary Self-Disclosures to Bureau of Industry & Security”! Below is the article reproduced with permission for your reading pleasure. We’d love to hear your feedback!

You can read the article here (where you’ll have the ability to access all of the great hyperlinks). Please note you cannot click on the hyperlinks below.

We’d love to hear your feedback!

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Incoterms 2020

Diaz Trade Law’s President, Jennifer Diaz,  and Associate Attorney, Denise Calle, are enthusiastic to announce Bloomberg Law published another one of our articles, “Incoterms 2020”! Below is the article reproduced with permission for your reading pleasure. We’d love to hear your feedback!

You can read the article here (where you’ll have the ability to access all of the great hyperlinks). Please note you cannot click on the hyperlinks below.

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FDA OPENS NEW FSVP PORTAL FOR IMPORTERS

The Foreign Supplier Verification Programs for Food Importers (FSVP), establishes guidelines for importers to vet their foreign manufacturers, ensuring that food products destined for the U.S. are safe for consumption. The FSVP was created under the Food Safety Modernization Act (FSMA). These standards of the FSVP are in line with the goals articulated in the U.S. Food and Drug Administration (FDA)  Strategy for the Safety of Imported Food. The FDA seeks to ensure that foreign-manufactured food products are safe for consumption. Further, as discussed in Diaz Trade Law’s previously published blog, the FDA issued its first FSVP warning letter in September 2019, and since then has issued at least 60 more!

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An Introduction to Safeguard Investigations

What is Section 201 ?

Section 201 of the Trade Act of 1974 provides import relief measures (also known as Safeguards) for domestic industries. The measures provide temporary relief for U.S. industries when competitor imports increase so significantly that they cause serious injury or threat to the domestic industry. The Safeguard measures are temporary – they allow the U.S. President to raise import duties or impose nontariff barriers on goods entering the United States for a limited period so that domestic industry is given sufficient time to adjust to the competition.

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REGISTER TODAY! NEI Accredited Webinar Importing 101 – Introduction to U.S. Customs

Webinar Importing 101 Introduction to US CustomsWhether you are new to importing or seasoned, this one-hour webinar is a must attend. Register today to hear directly from this specialized, expert trio on the “Top 10 Tips When Importing to Ensure Compliance” with real case studies:

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301 Exclusion Extensions for COVID-19 Related Products

On March 10, 2021, via Federal Register Notice ( 86 FR 13785), the United States Trade Representative (USTR) announced that 99 medical product exclusions will be extended from March 31, 2021, to September 30, 2021. This action extends a previous USTR action which extended these exclusions from December 31, 2020, to March 31, 2020 (85 FR 85831). […]

OTC Drug Manufacturers are Required to Pay FDA Facility User Fees by May 10, 2021

Co-Authored by Denise Calle.

On March 26, 2021, Food and Drug Administration (FDA) published the Federal Register Notice, “Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing the OTC Monograph Drug user fee program fee rates for FY 2021. This is the first year FDA has expanded user fees to OTC Drug Manufacturers and submitters of OTC monograph order requests.

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