Best Practices

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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Submitting a Voluntary Self-Disclosure to OFAC

Diaz Trade Law is enthusiastic to announce Bloomberg Law published another one of our articles, “Submitting a Voluntary Self-Disclosure to OFAC”! 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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Future of First Sale Rule in Question

On March 1, 2021, the Court of International Trade (CIT) denied Meyer Corporation’s claim for duty-free treatment under its attempted use of the first sale valuation and the Generalized System of Preferences (GSP), in Meyer Corporation, U.S. v. United States, Court No. 13-00154 (Meyer). This case sent a ripple through the trade-community as many speculate whether the decision signals an end of first sale for non-market countries.

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New AD/CVD Petition Against Imports of Certain Chinese Mobile Access Equipment

Co-Authored by Sharath Patil

Background on AD/CVD Investigations

Antidumping duty (“AD”) and countervailing duty (“CVD”) investigations are brought jointly by the U.S. International Trade Commission (“USITC”) and the U.S. Department of Commerce (“Commerce”). AD investigations are triggered when a domestic industry alleges that it has been injured by competing imports of particular goods from specific countries being sold at less than a fair value. Meanwhile, CVD investigations are triggered when a domestic industry alleges that it has been injured by competing imports that are being unfairly subsidized by their governments. The domestic industry initiating the investigation is known as the petitioner while the foreign industry participating in the investigation is known as the respondent.

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