Pre-compliance

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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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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Recent Government Data Indicates that Florida Trade is Rebounding Fast Despite Pandemic Hit

Co-Authored by Sharath Patil

COVID-19’s Impact on the Global Economy

The COVID-19 pandemic has had systemic implications for nearly every facet of our lives and society. The world of international trade is certainly no exception. Businesses and governments alike have had to figure out how to continue import and export operations while accounting for the risks present in the current trading climate. Challenges that importers and exporters have faced include: 1) dramatic demand spikes for certain goods, 2) equally dramatic crashes in demand for other goods, 3) significant back-ups of inflowing shipments at key ports, 4) an increase in trade restrictions and other barriers to trade, and 5) contractions in trade volumes, just to name a few.

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Biden Executive Order Strengthens Buy American Government Procurement Laws

Co-Authored by Sharath Patil

Biden Signs Executive Order Strengthening Buy American Laws

Buy American laws are a set of statutes, regulations, rules, and Executive Orders that require that the U.S. federal government require or provide preferences for purchasing goods produced in the United States. Buy American laws were created and continue to be amended with the intention of promoting economic and national security, stimulating economic growth, creating good jobs at decent wages, and supporting the U.S. manufacturing and defense industrial bases.

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